Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00839254
• Collaborator: (none)
• Enrollment: 6,181
• Locations: 15
• Arms: 8
• Actual Duration (Months): 35.4
• Patients Per Site: 412.1
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

Condition or Disease	Intervention/Treatment	Phase
Infections, Streptococcal; Streptococcus Pneumoniae	Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A); Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)	Phase 3

Detailed Description

The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
• Actual Study Start Date: Feb 18, 2009
• Actual Primary Completion Date: Jan 31, 2012
• Actual Study Completion Date: Jan 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10Pn3+1-6W-6M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A); 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Experimental: 10Pn2+1-6W-6M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A); 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Active Comparator: Ctrl3+1-6W-6M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.
Active Comparator: Ctrl2+1-6W-6M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.
Experimental: 10Pn7-11M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A); 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Active Comparator: Ctrl7-11M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.
Active Comparator: 10Pn12-18M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A); 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
Experimental: Ctrl12-18M/053 Group Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine); 2 Intramuscular injections only for children >= 12 months of age at the time of first study vaccination.

Outcome Measures

Primary Outcome Measures

1. Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

2. Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

Secondary Outcome Measures

1. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

2. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

3. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

4. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

5. Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

6. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

7. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

8. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).]

   The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

9. Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

   PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

10. Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

11. Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

12. Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

13. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

14. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

15. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

16. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

17. Person Year Rate in Prevention of All Tympanostomy Tube Placements- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

18. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

19. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

20. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

21. Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

22. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.]

    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

23. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

24. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule. [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.]

    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

25. Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course [Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - mean FU time=24 months.]

    Antimicrobial susceptibility classification of IPD isolates reported during IPD follow-up with percentages for each serotype for the following categories: S= susceptible; I = intermediate ; R = resistant; N = not available.

26. Number of Subjects With Lower Respiratory Tract Infections (LRTIs) (in a Subset of Subjects in Turku Area ) [From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).]

    Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one LRTI any time after the administration of the first vaccine dose was tabulated.

27. Number of Subjects With Upper Respiratory Tract Infections (URTIs) (in a Subset of Subjects in Turku Area ) [From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).]

    Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one URTI any time after the administration of the first vaccine dose was tabulated.

28. Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

29. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)]

    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature ≥ 38 degrees Celsius (°C) or oral/axillary/tympanic temperature equal to or above 37.5°C], irritability/fussiness and loss pf appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = rectal temperature > 40°C. Grade 3 irritability/fussiness = cried that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = a symptom assessed by investigator as causally related to the vaccination.

30. Number of Subjects With Any Unsolicited Adverse Events (AEs). [Within 31 days (31D) after each vaccination (M0+31D, M1+31D [only for 3+1 schedule], M2+31D, M8+31D [booster dose] for 6W-6M subjects; M0+31D, M2+31D, M6+31D [booster dose] for 7M-11M subjects; M0+31D, M6+31D for 12M-18M subjects)]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

31. Number of Subjects With Serious Adverse Events (SAEs). [Following administration of the first vaccine dose up to study end (M0 up to M18 for subjects aged 6W to 6M at enrollment; M0 up to M16 for subjects aged 7M to 11M at enrollment; M0 up to M9 for subjects aged 12M to 18M at enrollment)]

    An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.

32. Number of Subjects Enrolled and Vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 Study With Post-study SAEs Reported Via Passive Surveillance- Subjects Enrolled Aged 6 Weeks to 6 Months and 7 to 18 Months [From the end of the blinded ID Follow-Up period (at least 30 months from the study start) up to the end of 18-month period after study unblinding]

    An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.

33. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first +/- 1500 subjects from whom blood samples were collected, according to age and treatment groups).

34. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

35. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

36. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

37. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

38. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

39. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

40. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

41. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

42. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

43. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

44. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

45. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups). Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

46. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi /NTHi after differentiation from H. haemolyticus by PCR assay.

47. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

48. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

49. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster) at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

50. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

51. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first 1500 subjects from whom blood samples were collected, according to age and treatment groups).

52. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

53. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

54. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

55. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

56. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

57. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

58. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

59. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

60. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F -inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

61. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F-inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

62. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

63. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

64. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

65. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

66. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

67. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

68. ANTIBODY CONCENTRATIONS AGAINST PROTEIN D (ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

69. ANTIBODY CONCENTRATIONS AGAINST PROTEIN D(ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)]

    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

70. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

71. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN [At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

72. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

73. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN [At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)]

    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

74. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

75. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

76. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

77. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

78. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

79. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

80. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

81. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

82. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).]

    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

83. Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period. [Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).]

    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

84. Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period. [Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).]

    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.

• Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.

• Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.

• Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.

• Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.

• Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.

• Known severe hypersensitivity to any component of the study vaccines, including neomycin.

• Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Espoo		Finland	02100
2	GSK Investigational Site	Helsinki		Finland	00100
3	GSK Investigational Site	Helsinki		Finland	00930
4	GSK Investigational Site	Jarvenpaa		Finland	04400
5	GSK Investigational Site	Kokkola		Finland	67100
6	GSK Investigational Site	Kotka		Finland	48600
7	GSK Investigational Site	Kuopio		Finland	70210
8	GSK Investigational Site	Lahti		Finland	15140
9	GSK Investigational Site	Oulu		Finland	90220
10	GSK Investigational Site	Pori		Finland	28100
11	GSK Investigational Site	Seinajoki		Finland	60100
12	GSK Investigational Site	Tampere		Finland	33100
13	GSK Investigational Site	Turku		Finland	20520
14	GSK Investigational Site	Vantaa		Finland	01300
15	GSK Investigational Site	Vantaa		Finland	01600

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• Vesikari T, Forsten A, Seppä I, Kaijalainen T, Puumalainen T, Soininen A, Traskine M, Lommel P, Schoonbroodt S, Hezareh M, Moreira M, Borys D, Schuerman L. Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. J Pediatric Infect Dis Soc. 2016 Sep;5(3):237-248. doi: 10.1093/jpids/piw010. Epub 2016 Apr 28.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00839254
• Other Study ID Numbers: 112595; 2008-006551-51
• First Posted: Feb 9, 2009
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Streptococcus pneumoniae; acute otitis media; Pneumococcal conjugate vaccine; nasopharyngeal carriage; Haemophilus influenzae; immunogenicity; invasive disease
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections; Otitis; Otitis Media; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	This study is linked with 10PN-PD-DIT-043 (111442) study (NCT00861380.-EudraCT: 2008-005149-48) with which primary objectives and outcomes are common. Subjects of 10PN-PD-DIT-043 study contributed to the results of this study.
Pre-assignment Detail	Out of 6183 subjects enrolled, 6177 were analyzed:(6174 subjects and 3 of them received 2 subject numbers, without any impact on the results of the analyses. Total population assessed for combined analyses performed on both studies included 45977 subjects, see details in groups description.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Period Title: Overall Study
STARTED	1849	1316	1069	859	241	204	368	271
COMPLETED	1696	1224	979	797	204	178	340	256
NOT COMPLETED	153	92	90	62	37	26	28	15

Baseline Characteristics

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group	Total
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Total of all reporting groups
Overall Participants	1849	1316	1069	859	241	204	368	271	6177
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	2.4 (1.02)	2.3 (0.95)	2.6 (1.19)	2.4 (1)	9 (1.44)	8.7 (1.39)	15 (1.99)	15.2 (1.99)	7.2 (1.37)
Sex: Female, Male (Count of Participants)
Female	921 49.8%	681 51.7%	551 51.5%	393 45.8%	118 49%	113 55.4%	173 47%	142 52.4%	3092 50.1%
Male	928 50.2%	635 48.3%	518 48.5%	466 54.2%	123 51%	91 44.6%	195 53%	129 47.6%	3085 49.9%
Race/Ethnicity, Customized (Count of Participants)
African heritage / African American	1 0.1%	0 0%	0 0%	0 0%	1 0.4%	1 0.5%	2 0.5%	0 0%	5 0.1%
White - Arabic / north African heritage	7 0.4%	5 0.4%	4 0.4%	6 0.7%	3 1.2%	0 0%	2 0.5%	0 0%	27 0.4%
White - Caucasian / European heritage	1822 98.5%	1303 99%	1058 99%	845 98.4%	235 97.5%	201 98.5%	362 98.4%	270 99.6%	6096 98.7%
Unspecified	19 1%	8 0.6%	7 0.7%	8 0.9%	2 0.8%	2 1%	2 0.5%	1 0.4%	49 0.8%

Outcome Measures

1. Primary Outcome

Title	Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, including all vaccinated, subjects in the 10PN-PD-DIT-043 NCT00839254 study and vaccinated subjects of 10PN-PD-DIT-053 NCT00839254 study contributing to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10201
Number (95% Confidence Interval) [Participants per 1000 person-years]	0.000 0%	0.564 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10Pn3+1-6W-6M/043+053 Group, Ctrl-6W-6M/043+053 Group
	Comments	Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type [VT] IPD VE = 0%) was lower than (<) 5%.
	Type of Statistical Test	Superiority
	Comments	VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	VE (1-RR)
	Estimated Value	100
	Confidence Interval	(2-Sided) 95%; 82.8 to 100
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10201
Number (95% Confidence Interval) [Participants per 1000 person-years]	0.048 0%	0.564 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10Pn3+1-6W-6M/043+053 Group, Ctrl-6W-6M/043+053 Group
	Comments	Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type [VT] IPD VE = 0%) was lower than (<) 5%.
	Type of Statistical Test	Superiority
	Comments	VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.
Statistical Test of Hypothesis	p-Value	= 0.0009
	Comments	p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	VE (1-RR)
	Estimated Value	91.8
	Confidence Interval	(2-Sided) 95%; 58.3 to 99.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10201
Culture confirmed ID	0.093 0%	0.845 0.1%
Pneumococcal invasive disease (IPD)	0.000 0%	0.657 0%
Serotype 4	0.000 0%	0.000 0%
Serotype 6B	0.000 0%	0.235 0%
Serotype 7F	0.000 0%	0.000 0%
Serotype 14	0.000 0%	0.188 0%
Serotype 18C	0.000 0%	0.047 0%
Serotype 19F	0.000 0%	0.047 0%
Serotype 23F	0.000 0%	0.047 0%
Cross-reactive serotypes	0.000 0%	0.094 0%
Serotype 6A	0.000 0%	0.047 0%
Serotype 19A	0.000 0%	0.047 0%
Other pneumococcal serotypes	0.000 0%	0.000 0%
Serotype 3	0.000 0%	0.000 0%
Serotype 15C	0.000 0%	0.000 0%
H. influenzae ID	0.000 0%	0.047 0%
Non-typeable (NTHI)	0.000 0%	0.047 0%
Other bacteria	0.093 0%	0.188 0%
Neisseria meningitidis	0.093 0%	0.047 0%
Streptococcus pyogenes	0.000 0%	0.094 0%
Moraxella catarrhalis	0.000 0%	0.047 0%

4. Secondary Outcome

Title	Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10201
Culture confirmed ID	0.194 0%	0.845 0.1%
Pneumococcal invasive disease (IPD)	0.097 0%	0.657 0%
Vaccine serotypes (vaccine type-IPD)	0.048 0%	0.564 0%
Serotype 4	0.000 0%	0.000 0%
Serotype 6B	0.000 0%	0.235 0%
Serotype 7F	0.048 0%	0.000 0%
Serotype 14	0.000 0%	0.188 0%
Serotype 18C	0.000 0%	0.047 0%
Serotype 19F	0.000 0%	0.047 0%
Serotype 23F	0.000 0%	0.047 0%
Cross-reactive serotypes	0.000 0%	0.094 0%
Serotype 6A	0.000 0%	0.047 0%
Serotype 19A	0.000 0%	0.047 0%
Other pneumococcal serotypes	0.048 0%	0.000 0%
Serotype 3	0.048 0%	0.000 0%
Serotype 15C	0.000 0%	0.000 0%
H. influenzae ID	0.048 0%	0.047 0%
Non-typeable (NTHI)	0.048 0%	0.047 0%
Other bacteria	0.048 0%	0.188 0%
Neisseria meningitidis	0.048 0%	0.047 0%
Streptococcus pyogenes	0.000 0%	0.094 0%
Moraxella catarrhalis	0.000 0%	0.047 0%

5. Secondary Outcome

Title	Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1908
Culture confirmed ID	0.000 0%	0.446 0%
Pneumococcal invasive disease (IPD)	0.000 0%	0.446 0%
Vaccine serotypes (vaccine type-IPD)	0.000 0%	0.446 0%
Serotype 4	0.000 0%	0.000 0%
Serotype 6B	0.000 0%	0.000 0%
Serotype 7F	0.000 0%	0.223 0%
Serotype 14	0.000 0%	0.223 0%
Serotype 18C	0.000 0%	0.000 0%
Serotype 19F	0.000 0%	0.000 0%
Serotype 23F	0.000 0%	0.000 0%
Cross-reactive serotypes	0.000 0%	0.000 0%
Serotype 6A	0.000 0%	0.000 0%
Serotype 19A	0.000 0%	0.000 0%
Other pneumococcal serotypes	0.000 0%	0.000 0%
Serotype 3	0.000 0%	0.000 0%
Serotype 15C	0.000 0%	0.000 0%
H. influenzae ID	0.000 0%	0.000 0%
Non-typeable (NTHI)	0.000 0%	0.000 0%
Other bacteria	0.000 0%	0.000 0%

6. Secondary Outcome

Title	Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6535	3126
Culture confirmed ID	0.000 0%	0.674 0.1%
Pneumococcal invasive disease (IPD)	0.000 0%	0.674 0.1%
Vaccine serotypes (vaccine type-IPD)	0.000 0%	0.404 0%
Serotype 4	0.000 0%	0.135 0%
Serotype 6B	0.000 0%	0.135 0%
Serotype 7F	0.000 0%	0.000 0%
Serotype 14	0.000 0%	0.000 0%
Serotype 18C	0.000 0%	0.000 0%
Serotype 19F	0.000 0%	0.135 0%
Serotype 23F	0.000 0%	0.000 0%
Cross-reactive serotypes	0.000 0%	0.000 0%
Serotype 6A	0.000 0%	0.000 0%
Serotype 19A	0.000 0%	0.000 0%
Other pneumococcal serotypes	0.000 0%	0.269 0%
Serotype 3	0.000 0%	0.135 0%
Serotype 15C	0.000 0%	0.135 0%
H. influenzae ID	0.000 0%	0.000 0%
Non-typeable (NTHI)	0.000 0%	0.000 0%
Other bacteria	0.000 0%	0.000 0%

7. Secondary Outcome

Title	Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10201
Probable cases of IPD	0.000 0%	0.141 0%
Confirmed or probable cases of IPD	0.000 0%	0.798 0.1%

8. Secondary Outcome

Title	Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10201
Probable cases of IPD	0.000 0%	0.141 0%
Confirmed or probable cases of IPD	0.097 0%	0.798 0.1%

9. Secondary Outcome

Title	Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1908
Probable cases of IPD	0.000 0%	0.000 0%
Confirmed or probable cases of IPD	0.000 0%	0.446 0%

10. Secondary Outcome

Title	Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6535	3126
Probable cases of IPD	0.000 0%	0.000 0%
Confirmed or probable cases of IPD	0.000 0%	0.674 0.1%

11. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10200
Number (95% Confidence Interval) [Participants per 1000 person-years]	10.131 0.5%	13.854 1.1%

12. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10200
Number (95% Confidence Interval) [Participants per 1000 person-years]	10.155 0.5%	13.854 1.1%

13. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination in the 7-11 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1907
Number (95% Confidence Interval) [Participants per 1000 person-years]	10.263 0.6%	15.752 1.2%

14. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination in the 12-18 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6534	3126
Number (95% Confidence Interval) [Participants per 1000 person-years]	9.322 0.5%	11.739 0.9%

15. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10200
Consolidated pneumonia	2.181 0.1%	3.965 0.3%
Non-consolidated pneumonia	2.908 0.2%	2.937 0.2%
Consolidated or non-consolidated pneumonia	5.090 0.3%	6.903 0.5%

16. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10200
Consolidated pneumonia	2.273 0.1%	3.965 0.3%
Non-consolidated pneumonia	2.627 0.1%	2.937 0.2%
Consolidated or non-consolidated pneumonia	4.901 0.3%	6.903 0.5%

17. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called aslo 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1907
Consolidated pneumonia	1.960 0.1%	4.401 0.3%
Non-consolidated pneumonia	3.344 0.2%	4.865 0.4%
Consolidated or non-consolidated pneumonia	5.305 0.3%	9.266 0.7%

18. Secondary Outcome

Title	Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6534	3126
Consolidated pneumonia	1.824 0.1%	3.494 0.3%
Non-consolidated pneumonia	2.837 0.2%	2.935 0.2%
Consolidated or non-consolidated pneumonia	4.661 0.3%	6.428 0.5%

19. Secondary Outcome

Title	Person Year Rate in Prevention of All Tympanostomy Tube Placements- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10200
Number (95% Confidence Interval) [Participants per 1000 person-years]	68.735 3.7%	79.504 6%

20. Secondary Outcome

Title	Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10200
Number (95% Confidence Interval) [Participants per 1000 person-years]	66.083 3.6%	79.504 6%

21. Secondary Outcome

Title	Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 7-11 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1907
Number (95% Confidence Interval) [Participants per 1000 person-years]	68.153 3.7%	79.920 6.1%

22. Secondary Outcome

Title	Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 12-18 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6534	3126
Number (95% Confidence Interval) [Participants per 1000 person-years]	56.809 3.1%	58.973 4.5%

23. Secondary Outcome

Title	Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10200
Antimicrobial prescriptions (ATC code J01)	1592.585 86.1%	1706.194 129.7%
For otitis media and respiratory infections	1451.141 78.5%	1565.692 119%

24. Secondary Outcome

Title	Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course.
Description	PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 2-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10054	10200
Antimicrobial prescriptions (ATC code J01)	1552.493 84%	1706.194 129.7%
For otitis media and respiratory infections	1415.983 76.6%	1565.692 119%

25. Secondary Outcome

Title	Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 7 and 11 months of age.

Arm/Group Title	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	3880	1907
Antimicrobial prescriptions (ATC code J01)	1536.618 83.1%	1649.360 125.3%
For otitis media and respiratory infections	1390.856 75.2%	1499.713 114%

26. Secondary Outcome

Title	Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule.
Description	PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Catch-up Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with a 2-dose primary vaccination between 12 and 18 months of age.

Arm/Group Title	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	6534	3126
Antimicrobial prescriptions (ATC code J01)	1315.936 71.2%	1421.774 108%
For otitis media and respiratory infections	1177.729 63.7%	1271.268 96.6%

27. Secondary Outcome

Title	Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course
Description	Antimicrobial susceptibility classification of IPD isolates reported during IPD follow-up with percentages for each serotype for the following categories: S= susceptible; I = intermediate ; R = resistant; N = not available.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - mean FU time=24 months.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	0	2	24
Serotype-4 -Pencillin-S	0 0%	1 0.1%
Serotype-6A -Pencillin-S	0 0%	1 0.1%
Serotype-6B -Pencillin-I	0 0%	3 0.2%
Serotype-6B -Pencillin-R	0 0%	1 0.1%
Serotype-6B -Pencillin-S	0 0%	2 0.2%
Serotype-7F -Pencillin-S	1 0.1%	1 0.1%
Serotype-14 -Pencillin-I	0 0%	2 0.2%
Serotype-14 -Pencillin-R	0 0%	1 0.1%
Serotype-14 -Pencillin-S	0 0%	2 0.2%
Serotype-15C -Pencillin-S	0 0%	1 0.1%
Serotype-18C -Pencillin-S	0 0%	1 0.1%
Serotype-19A -Pencillin-I	0 0%	1 0.1%
Serotype-19F -Pencillin-I	0 0%	1 0.1%
Serotype-19F -Pencillin-S	0 0%	1 0.1%
Serotype-23F -Pencillin-S	0 0%	1 0.1%
Serotype-N -Pencillin-N	1 0.1%	4 0.3%
Serotype-4 -Erythromycin-S	0 0%	1 0.1%
Serotype-6A -Erythromycin-S	0 0%	1 0.1%
Serotype-6B -Erythromycin-R	0 0%	5 0.4%
Serotype-6B -Erythromycin-S	0 0%	1 0.1%
Serotype-7F -Erythromycin-S	1 0.1%	1 0.1%
Serotype-14 -Erythromycin-R	0 0%	4 0.3%
Serotype-14 -Erythromycin-S	0 0%	1 0.1%
Serotype-15C -Erythromycin-S	0 0%	1 0.1%
Serotype-18C -Erythromycin-S	0 0%	1 0.1%
Serotype-19A -Erythromycin-S	0 0%	1 0.1%
Serotype-19F -Erythromycin-R	0 0%	1 0.1%
Serotype-19F -Erythromycin-S	0 0%	1 0.1%
Serotype-23F -Erythromycin-S	0 0%	1 0.1%
Serotype-N -Erythromycin-N	1 0.1%	4 0.3%
Serotype-4 -Tetracyclin-S	0 0%	1 0.1%
Serotype-6A -Tetracyclin-S	0 0%	1 0.1%
Serotype-6B -Tetracyclin-R	0 0%	4 0.3%
Serotype-6B -Tetracyclin-S	0 0%	2 0.2%
Serotype-7F -Tetracyclin-S	1 0.1%	1 0.1%
Serotype-14 -Tetracyclin-S	0 0%	5 0.4%
Serotype-15C -Tetracyclin-S	0 0%	1 0.1%
Serotype-18C -Tetracyclin-S	0 0%	1 0.1%
Serotype-19A -Tetracyclin-S	0 0%	1 0.1%
Serotype-19F -Tetracyclin-R	0 0%	1 0.1%
Serotype-19F -Tetracyclin-S	0 0%	1 0.1%
Serotype-23F -Tetracyclin-S	0 0%	1 0.1%
Serotype-N -Tetracyclin-N	1 0.1%	4 0.3%
Serotype-4 -Levoffloxacin-S	0 0%	1 0.1%
Serotype-6A -Levoffloxacin-S	0 0%	1 0.1%
Serotype-6B -Levoffloxacin-S	0 0%	6 0.5%
Serotype-7F -Levoffloxacin-S	1 0.1%	1 0.1%
Serotype-14 -Levoffloxacin-S	0 0%	5 0.4%
Serotype-15C -Levoffloxacin-S	0 0%	1 0.1%
Serotype-18C -Levoffloxacin-S	0 0%	1 0.1%
Serotype-19A -Levoffloxacin-S	0 0%	1 0.1%
Serotype-19F -Levoffloxacin-S	0 0%	2 0.2%
Serotype-23F -Levoffloxacin-S	0 0%	1 0.1%
Serotype-N -Levoffloxacin-N	1 0.1%	4 0.3%
Serotype-4 -Ceftriaxone-S	0 0%	1 0.1%
Serotype-6A -Ceftriaxone-S	0 0%	1 0.1%
Serotype-6B -Ceftriaxone-S	0 0%	6 0.5%
Serotype-7F -Ceftriaxone-S	1 0.1%	1 0.1%
Serotype-14 -Ceftriaxone-I	0 0%	1 0.1%
Serotype-14 -Ceftriaxone-S	0 0%	4 0.3%
Serotype-15C -Ceftriaxone-S	0 0%	1 0.1%
Serotype-18C -Ceftriaxone-S	0 0%	1 0.1%
Serotype-19A -Ceftriaxone-S	0 0%	1 0.1%
Serotype-19F -Ceftriaxone-S	0 0%	2 0.2%
Serotype-23F -Ceftriaxone-S	0 0%	1 0.1%
Serotype-N -Ceftriaxone-N	1 0.1%	4 0.3%
Serotype-4 -Clindamycin-S	0 0%	1 0.1%
Serotype-6A -Clindamycin-S	0 0%	1 0.1%
Serotype-6B -Clindamycin-R	0 0%	4 0.3%
Serotype-6B -Clindamycin-S	0 0%	2 0.2%
Serotype-7F -Clindamycin-S	1 0.1%	1 0.1%
Serotype-14 -Clindamycin-N	0 0%	1 0.1%
Serotype-14 -Clindamycin-S	0 0%	4 0.3%
Serotype-15C -Clindamycin-S	0 0%	1 0.1%
Serotype-18C -Clindamycin-S	0 0%	1 0.1%
Serotype-19A -Clindamycin-S	0 0%	1 0.1%
Serotype-19F -Clindamycin-R	0 0%	1 0.1%
Serotype-19F -Clindamycin-S	0 0%	1 0.1%
Serotype-23F -Clindamycin-S	0 0%	1 0.1%
Serotype-N -Clindamycin-N	1 0.1%	4 0.3%

28. Secondary Outcome

Title	Number of Subjects With Lower Respiratory Tract Infections (LRTIs) (in a Subset of Subjects in Turku Area )
Description	Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one LRTI any time after the administration of the first vaccine dose was tabulated.
Time Frame	From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed in a subset of vaccinated subjects including all vaccinated subjects enrolled in the 10PNPD-DIT-053 study in the Turku area and those vaccinated subjects enrolled in the 10PN-PD-DIT-043 study in the Turku area who agreed to take part in this assessment.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	243	190	171	31	22	62	48
Count of Participants [Participants]	19 1%	19 1.4%	19 1.8%	3 0.3%	1 0.4%	5 2.5%	2 0.5%

29. Secondary Outcome

Title	Number of Subjects With Upper Respiratory Tract Infections (URTIs) (in a Subset of Subjects in Turku Area )
Description	Analysis of this outcome was performed in the Turku area. The number of subjects reporting at least one URTI any time after the administration of the first vaccine dose was tabulated.
Time Frame	From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed in a subset of vaccinated subjects including all vaccinated subjects enrolled in the 10PNPD-DIT-053 study in the Turku area and those vaccinated subjects enrolled in the 10PN-PD-DIT-043 study in the Turku area who agreed to take part in this assessment.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group	10Pn7-11M/043+053 Group	Ctrl7-11M/043+053 Group	10Pn12-18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PNPD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	243	190	171	31	22	62	48
Count of Participants [Participants]	158 8.5%	124 9.4%	94 8.8%	14 1.6%	15 6.2%	27 13.2%	19 5.2%

30. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time Frame	Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	1846	1302	1066	852	237	202	363	270
Any Pain, Dose 1	807 43.6%	611 46.4%	146 13.7%	106 12.3%	120 49.8%	33 16.2%	220 59.8%	65 24%
Grade 3 Pain, Dose 1	60 3.2%	43 3.3%	2 0.2%	3 0.3%	6 2.5%	0 0%	19 5.2%	0 0%
Any Redness (mm), Dose 1	936 50.6%	675 51.3%	270 25.3%	214 24.9%	137 56.8%	48 23.5%	203 55.2%	93 34.3%
Grade 3 Redness (mm), Dose 1	56 3%	48 3.6%	3 0.3%	0 0%	17 7.1%	0 0%	39 10.6%	0 0%
Any Swelling (mm), Dose 1	636 34.4%	471 35.8%	88 8.2%	64 7.5%	107 44.4%	19 9.3%	142 38.6%	25 9.2%
Grade 3 Swelling (mm), Dose 1	89 4.8%	69 5.2%	4 0.4%	1 0.1%	20 8.3%	9 4.4%	35 9.5%	1 0.4%
Any Pain, Dose 2	662 35.8%	509 38.7%	114 10.7%	94 10.9%	108 44.8%	38 18.6%	242 65.8%	78 28.8%
Grade 3 Pain, Dose 2	23 1.2%	28 2.1%	2 0.2%	1 0.1%	11 4.6%	0 0%	45 12.2%	0 0%
Any Redness (mm), Dose 2	996 53.9%	690 52.4%	254 23.8%	203 23.6%	124 51.5%	57 27.9%	193 52.4%	85 31.4%
Grade 3 Redness (mm), Dose 2	48 2.6%	63 4.8%	3 0.3%	0 0%	21 8.7%	0 0%	49 13.3%	1 0.4%
Any Swelling (mm), Dose 2	686 37.1%	536 40.7%	114 10.7%	79 9.2%	98 40.7%	18 8.8%	148 40.2%	26 9.6%
Grade 3 Swelling (mm), Dose 2	67 3.6%	91 6.9%	4 0.4%	1 0.1%	19 7.9%	0 0%	34 9.2%	0 0%
Any Pain, Dose 3	538 29.1%	102 7.8%
Grade 3 Pain, Dose 3	12 0.6%	2 0.2%
Any Redness (mm), Dose 3	963 52.1%	300 22.8%
Grade 3 Redness (mm), Dose 3	52 2.8%	0 0%
Any Swelling (mm), Dose 3	676 36.6%	144 10.9%
Grade 3 Swelling (mm), Dose 3	62 3.4%	1 0.1%
Any Pain, Booster dose	888 48%	710 54%	250 23.4%	171 19.9%	123 51%	40 19.6%
Grade 3 Pain, Booster dose	66 3.6%	41 3.1%	2 0.2%	2 0.2%	14 5.8%	2 1%
Any Redness (mm), Booster dose	913 49.4%	702 53.3%	345 32.3%	238 27.7%	106 44%	54 26.5%
Grade 3 Redness (mm), Booster dose	102 5.5%	103 7.8%	13 1.2%	2 0.2%	18 7.5%	0 0%
Any Swelling (mm), Booster dose	716 38.7%	586 44.5%	229 21.4%	118 13.7%	85 35.3%	31 15.2%
Grade 3 Swelling (mm), Booster dose	102 5.5%	111 8.4%	10 0.9%	3 0.3%	14 5.8%	0 0%

31. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Description	Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature ≥ 38 degrees Celsius (°C) or oral/axillary/tympanic temperature equal to or above 37.5°C], irritability/fussiness and loss pf appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = rectal temperature > 40°C. Grade 3 irritability/fussiness = cried that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = a symptom assessed by investigator as causally related to the vaccination.
Time Frame	Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	1846	1302	1066	852	237	202	363	270
Any Drowsiness, Dose 1	1070 57.9%	742 56.4%	462 43.2%	384 44.7%	106 44%	62 30.4%	155 42.1%	87 32.1%
Grade 3 Drowsiness, Dose 1	11 0.6%	8 0.6%	5 0.5%	1 0.1%	1 0.4%	0 0%	1 0.3%	2 0.7%
Related Drowsiness, Dose 1	1054 57%	738 56.1%	453 42.4%	374 43.5%	103 42.7%	57 27.9%	152 41.3%	81 29.9%
Any Temperature (Rectally)/(°C), Dose 1	388 21%	289 22%	82 7.7%	78 9.1%	38 15.8%	16 7.8%	74 20.1%	28 10.3%
Grade 3 Temperature (Rectally)/(°C), Dose 1	2 0.1%	0 0%	1 0.1%	0 0%	8 3.3%	0 0%	2 0.5%	2 0.7%
Related Temperature (Rectally)/(°C), Dose 1	381 20.6%	284 21.6%	78 7.3%	74 8.6%	35 14.5%	13 6.4%	69 18.8%	25 9.2%
Any Irritability, Dose 1	1325 71.7%	942 71.6%	577 54%	468 54.5%	157 65.1%	90 44.1%	210 57.1%	103 38%
Grade 3 Irritability, Dose 1	76 4.1%	56 4.3%	20 1.9%	14 1.6%	3 1.2%	2 1%	6 1.6%	4 1.5%
Related Irritability, Dose 1	1298 70.2%	937 71.2%	565 52.9%	460 53.6%	157 65.1%	83 40.7%	201 54.6%	96 35.4%
Any Loss of appetite, Dose 1	499 27%	335 25.5%	202 18.9%	147 17.1%	84 34.9%	56 27.5%	128 34.8%	82 30.3%
Grade 3 Loss of appetite, Dose 1	1 0.1%	3 0.2%	2 0.2%	0 0%	0 0%	1 0.5%	2 0.5%	4 1.5%
Related Loss of appetite, Dose 1	480 26%	332 25.2%	196 18.3%	140 16.3%	81 33.6%	48 23.5%	123 33.4%	73 26.9%
Any Drowsiness, Dose 2	868 46.9%	572 43.5%	332 31.1%	258 30%	88 36.5%	52 25.5%	126 34.2%	58 21.4%
Grade 3 Drowsiness, Dose 2	7 0.4%	6 0.5%	1 0.1%	3 0.3%	2 0.8%	1 0.5%	2 0.5%	1 0.4%
Related Drowsiness, Dose 2	855 46.2%	564 42.9%	329 30.8%	247 28.8%	85 35.3%	51 25%	123 33.4%	55 20.3%
Any Temperature (Rectally)/(°C), Dose 2	380 20.6%	382 29%	78 7.3%	80 9.3%	44 18.3%	20 9.8%	55 14.9%	11 4.1%
Grade 3 Temperature (Rectally)/(°C), Dose 2	2 0.1%	0 0%	0 0%	0 0%	0 0%	1 0.5%	2 0.5%	1 0.4%
Related Temperature (Rectally)/(°C), Dose 2	373 20.2%	378 28.7%	78 7.3%	71 8.3%	43 17.8%	15 7.4%	53 14.4%	8 3%
Any Irritability, Dose 2	1254 67.8%	822 62.5%	532 49.8%	408 47.5%	139 57.7%	94 46.1%	193 52.4%	72 26.6%
Grade 3 Irritability, Dose 2	73 3.9%	44 3.3%	13 1.2%	14 1.6%	7 2.9%	1 0.5%	3 0.8%	0 0%
Related Irritability, Dose 2	1236 66.8%	816 62%	523 48.9%	396 46.1%	137 56.8%	93 45.6%	191 51.9%	71 26.2%
Any Loss of appetite, Dose 2	434 23.5%	323 24.5%	187 17.5%	149 17.3%	69 28.6%	56 27.5%	109 29.6%	57 21%
Grade 3 Loss of appetite, Dose 2	4 0.2%	2 0.2%	1 0.1%	3 0.3%	44 18.3%	0 0%	2 0.5%	1 0.4%
Related Loss of appetite, Dose 2	419 22.7%	318 24.2%	181 16.9%	135 15.7%	0 0%	52 25.5%	105 28.5%	54 19.9%
Any Drowsiness, Dose 3	645 34.9%	293 22.3%
Grade 3 Drowsiness, Dose 3	2 0.1%	2 0.2%
Related Drowsiness, Dose 3	638 34.5%	285 21.7%
Any Temperature (Rectally)/(°C), Dose 3	347 18.8%	110 8.4%
Grade 3 Temperature (Rectally)/(°C), Dose 3	1 0.1%	1 0.1%
Related Temperature (Rectally)/(°C), Dose 3	336 18.2%	106 8.1%
Any Irritability, Dose 3	1115 60.3%	496 37.7%
Grade 3 Irritability, Dose 3	41 2.2%	14 1.1%
Related Irritability, Dose 3	1100 59.5%	492 37.4%
Any Loss of appetite, Dose 3	349 18.9%	178 13.5%
Grade 3 Loss of appetite, Dose 3	3 0.2%	0 0%
Related Loss of appetite, Dose 3	336 18.2%	172 13.1%
Any Drowsiness, Booster dose	721 39%	561 42.6%	307 28.7%	243 28.3%	92 38.2%	47 23%
Grade 3 Drowsiness, Booster dose	8 0.4%	8 0.6%	3 0.3%	4 0.5%	2 0.8%	1 0.5%
Related Drowsiness, Booster dose	699 37.8%	548 41.6%	300 28.1%	233 27.1%	87 36.1%	46 22.5%
Any Temperature (Rectally)/(°C), Booster dose	391 21.1%	333 25.3%	142 13.3%	120 14%	42 17.4%	11 5.4%
Grade 3 Temperature (Rectally)/(°C), Booster dose	3 0.2%	0 0%	0 0%	1 0.1%	1 0.4%	0 0%
Related Temperature (Rectally)/(°C), Booster dose	371 20.1%	319 24.2%	134 12.5%	110 12.8%	41 17%	8 3.9%
Any Irritability, Booster dose	1124 60.8%	816 62%	491 45.9%	410 47.7%	129 53.5%	84 41.2%
Grade 3 Irritability, Booster dose	47 2.5%	33 2.5%	14 1.3%	7 0.8%	2 0.8%	1 0.5%
Related Irritability, Booster dose	1085 58.7%	801 60.9%	481 45%	395 46%	124 51.5%	80 39.2%
Any Loss of appetite, Booster dose	549 29.7%	411 31.2%	260 24.3%	186 21.7%	64 26.6%	46 22.5%
Grade 3 Loss of appetite, Booster dose	12 0.6%	5 0.4%	6 0.6%	3 0.3%	2 0.8%	1 0.5%
Related Loss of appetite, Booster dose	513 27.7%	398 30.2%	253 23.7%	173 20.1%	60 24.9%	43 21.1%

32. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	Within 31 days (31D) after each vaccination (M0+31D, M1+31D [only for 3+1 schedule], M2+31D, M8+31D [booster dose] for 6W-6M subjects; M0+31D, M2+31D, M6+31D [booster dose] for 7M-11M subjects; M0+31D, M6+31D for 12M-18M subjects)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	1849	1316	1069	859	241	204	368	271
Unsolicited AEs, Primary vaccination	1105 59.8%	598 45.4%	554 51.8%	337 39.2%	157 65.1%	132 64.7%	221 60.1%	174 64.2%
Unsolicited AEs, Booster vaccination	521 28.2%	363 27.6%	277 25.9%	244 28.4%	51 21.2%	48 23.5%

33. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs).
Description	An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
Time Frame	Following administration of the first vaccine dose up to study end (M0 up to M18 for subjects aged 6W to 6M at enrollment; M0 up to M16 for subjects aged 7M to 11M at enrollment; M0 up to M9 for subjects aged 12M to 18M at enrollment)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group	10Pn7-11M/053 Group	Ctrl7-11M/053 Group	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	1849	1316	1069	859	241	204	368	271
Count of Participants [Participants]	163 8.8%	96 7.3%	77 7.2%	74 8.6%	24 10%	18 8.8%	23 6.3%	14 5.2%

34. Secondary Outcome

Title	Number of Subjects Enrolled and Vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 Study With Post-study SAEs Reported Via Passive Surveillance- Subjects Enrolled Aged 6 Weeks to 6 Months and 7 to 18 Months
Description	An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
Time Frame	From the end of the blinded ID Follow-Up period (at least 30 months from the study start) up to the end of 18-month period after study unblinding

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 study with post-study SAEs reported via passive surveillance.

Arm/Group Title	10Pn3+1-6W- 6M/043+053 Group	10Pn2+1-6W- 6M/043+053 Group	Ctrl-6W-6M/043+053 Group	10Pn7- 11M/043+053 Group	Ctrl7-11M/043+053 Group	10Pn12- 18M/043+053 Group	Ctrl12-18M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3689 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for 10Pn7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 1812 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 7 to 11 months at enrolment. Subjects received the Engerix B-thio free (or HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months 1908 since the previous vaccine dose (minimum 4 months) (7-11M Schedule). Refer to group description for Ctrl7-11M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 6249 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 3020 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 12 to 18 months at enrolment. Subjects received the Synflorix (or 10Pn-PD-DiT, or 10Pn) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/053 Group for details on vaccine specifics and administration route in this group.
Measure Participants	10273	10054	10201	3880	1908	6535	3126
Count of Participants [Participants]	1 0.1%	2 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%

35. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first +/- 1500 subjects from whom blood samples were collected, according to age and treatment groups).
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	49	31	56
6 Months	412	323	464
11-12 Months	500	383	604
14-15 Months	512	370	638
18-22 Months	503	430	736

36. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	69	58
9-13 Months	79	56
13-17 Months	81	87
16-20 Months	75	72
23-27 Months	68	75

37. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	125	88
19-25 Months	152	112
21-27 Months	132	105

38. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	29	18	30
6 Months	183	159	237
11-12 Months	229	178	342
14-15 Months	209	153	364
18-22 Months	169	176	404

39. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	44	34
9-13 Months	43	35
13-17 Months	43	55
16-20 Months	34	47
23-27 Months	28	48

40. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	70	57
19-25 Months	69	70
21-27 Months	64	53

41. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1780	1269	1874
11-12 Months	331 17.9%	246 18.7%	415 38.8%
14-15 Months	562 30.4%	400 30.4%	692 64.7%
18-22 Months	818 44.2%	609 46.3%	1023 95.7%

42. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	226	195
9-13 Months	36 1.9%	30 2.3%
13-17 Months	78 4.2%	83 6.3%
16-20 Months	95 5.1%	100 7.6%
23-27 Months	117 6.3%	116 8.8%

43. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	333	249
19-25 Months	130 7%	94 7.1%
21-27 Months	166 9%	133 10.1%

44. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1780	1269	1874
11-12 Months	131 7.1%	97 7.4%	223 20.9%
14-15 Months	221 12%	156 11.9%	387 36.2%
18-22 Months	326 17.6%	269 20.4%	626 58.6%

45. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	226	195
9-13 Months	18 1%	17 1.3%
13-17 Months	41 2.2%	51 3.9%
16-20 Months	50 2.7%	70 5.3%
23-27 Months	62 3.4%	88 6.7%

46. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.
Time Frame	At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	333	249
19-25 Months	53 2.9%	55 4.2%
21-27 Months	78 4.2%	74 5.6%

47. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups). Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	6	4	10
6 Months	57	36	46
11-12 Months	84	72	87
14-15 Months	121	84	92
18-22 Months	211	128	190

48. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi /NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	6	8
9-13 Months	8	9
13-17 Months	22	14
16-20 Months	17	13
23-27 Months	21	15

49. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	21	12
19-25 Months	24	21
21-27 Months	27	29

50. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1780	1269	1874
11-12 Months	77 4.2%	65 4.9%	83 7.8%
14-15 Months	176 9.5%	139 10.6%	157 14.7%
18-22 Months	349 18.9%	240 18.2%	313 29.3%

51. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster) at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	226	195
9-13 Months	8 0.4%	9 0.7%
13-17 Months	29 1.6%	19 1.4%
16-20 Months	37 2%	28 2.1%
23-27 Months	55 3%	39 3%

52. Secondary Outcome

Title	NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.
Time Frame	At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	333	249
19-25 Months	19 1%	20 1.5%
21-27 Months	37 2%	41 3.1%

53. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first 1500 subjects from whom blood samples were collected, according to age and treatment groups).
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	57	58	76
6 Months	459	345	486
11-12 Months	671	493	733
14-15 Months	612	466	668
18-22 Months	794	566	780

54. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	69	59
9-13 Months	73	61
13-17 Months	109	98
16-20 Months	91	81
23-27 Months	83	63

55. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	143	72
19-25 Months	167	129
21-27 Months	143	120

56. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	0	0	1
6 Months	10	5	8
11-12 Months	9	8	5
14-15 Months	4	5	10
18-22 Months	5	5	7

57. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	1	1
9-13 Months	0	3
13-17 Months	0	1
16-20 Months	0	2
23-27 Months	2	1

58. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	3	0
19-25 Months	2	0
21-27 Months	0	2

59. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).
Time Frame	At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1803	1289	1897
3 Months	111	108	144
6 Months	762	515	796
11-12 Months	468	306	462
14-15 Months	387	282	373
18-22 Months	255	182	266

60. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	236	200
7-11 Months	60	53
9-13 Months	53	63
13-17 Months	32	26
16-20 Months	34	31
23-27 Months	30	36

61. Secondary Outcome

Title	NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.
Time Frame	At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The Total Vaccinated cohort for analysis of carriage included all vaccinated subjects for whom data concerning carriage outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	358	265
12-18 Months	45	38
19-25 Months	47	41
21-27 Months	39	40

62. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN
Description	Antibody concentrations were measured by 22F -inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	209	123
ANTI-1, 6 months	1.86	0.03
ANTI-1, 11-12 months	0.54	0.03
ANTI-1, 12-13 months	2.13	0.03
ANTI-1, 18-22 months	0.50	0.04
ANTI-4, 6 months	2.47	0.03
ANTI-4, 11-12 months	0.97	0.03
ANTI-4, 12-13	3.61	0.03
ANTI-4, 18-22	0.62	0.03
ANTI-5, 6 months	2.73	0.03
ANTI-5, 11-12 months	1.07	0.04
ANTI-5, 12-13	3.27	0.05
ANTI-5, 18-22	0.85	0.10
ANTI-6B, 6 months	0.51	0.03
ANTI-6B, 11-12 months	0.58	0.03
ANTI-6B, 12-13	1.43	0.03
ANTI-6B, 18-22	0.60	0.04
ANTI-7F, 6 months	2.90	0.03
ANTI-7F, 11-12 months	1.56	0.04
ANTI-7F, 12-13 months	4.25	0.04
ANTI-7F, 18-22 months	1.19	0.05
ANTI-9V, 6 months	2.23	0.03
ANTI-9V, 11-12 months	1.35	0.03
ANTI-9V, 12-13 months	3.98	0.03
ANTI-9V, 18-22 months	1.32	0.03
ANTI-14, 6 months	5.00	0.07
ANTI-14, 11-12 months	2.52	0.05
ANTI-14, 12-13 months	6.40	0.06
ANTI-14, 18-22 months	1.98	0.08
ANTI-18C, 6 months	6.51	0.03
ANTI-18C, 11-12 months	2.45	0.03
ANTI-18C, 12-13 months	10.43	0.03
ANTI-18C, 18-22 months	2.18	0.04
ANTI-19F, 6 months	5.91	0.06
ANTI-19F, 11-12 months	2.73	0.05
ANTI-19F, 12-13 months	8.04	0.04
ANTI-19F, 18-22 months	2.17	0.07
ANTI-23F, 6 months	0.68	0.03
ANTI-23F, 11-12 months	0.73	0.03
ANTI-23F, 12-13 months	2.30	0.03
ANTI-23F, 18-22 months	0.95	0.05

63. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN
Description	Antibody concentrations were measured by 22F-inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn2+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	209	142
ANTI-1, 6 months	1.37	0.03
ANTI-1, 11-12 months	0.42	0.03
ANTI-1, 12-13 months	1.91	0.04
ANTI-1, 18-22 months	0.36	0.05
ANTI-4, 6 months	1.87	0.03
ANTI-4, 11-12 months	0.72	0.03
ANTI-4, 12-13 months	3.16	0.03
ANTI-4, 18-22 months	0.59	0.03
ANTI-5, 6 months	1.97	0.03
ANTI-5, 11-12 months	0.71	0.04
ANTI-5, 12-13 months	2.82	0.06
ANTI-5, 18-22 months	0.83	0.09
ANTI-6B, 6 months	0.32	0.03
ANTI-6B, 11-12 months	0.42	0.03
ANTI-6B, 12-13 months	1.43	0.03
ANTI-6B, 18-22 months	0.58	0.06
ANTI-7F, 6 months	1.76	0.03
ANTI-7F, 11-12 months	0.96	0.03
ANTI-7F, 12-13 months	3.62	0.03
ANTI-7F, 18-22 months	1.27	0.04
ANTI-9V, 6 months	1.38	0.03
ANTI-9V, 11-12 months	0.87	0.03
ANTI-9V, 12-13 months	3.88	0.03
ANTI-9V, 18-22 months	0.92	0.04
ANTI-14, 6 months	3.31	0.06
ANTI-14, 11-12 months	1.32	0.04
ANTI-14, 12-13 months	4.84	0.06
ANTI-14, 18-22 months	1.57	0.12
ANTI-18C, 6 months	3.38	0.04
ANTI-18C, 11-12 months	1.49	0.03
ANTI-18C, 12-13 months	10.60	0.03
ANTI-18C, 18-22 months	2.16	0.04
ANTI-19F, 6 months	3.40	0.06
ANTI-19F, 11-12 months	1.51	0.03
ANTI-19F, 12-13 months	7.41	0.04
ANTI-19F, 18-22 months	2.10	0.07
ANTI-23F, 6 months	0.54	0.04
ANTI-23F, 11-12 months	0.42	0.03
ANTI-23F, 12-13 months	2.18	0.03
ANTI-23F, 18-22 months	0.75	0.04

64. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	208	122
ANTI-6A, 6 months	0.13	0.03
ANTI-6A, 11-12 months	0.19	0.03
ANTI-6A, 12-13 months	0.53	0.03
ANTI-6A, 18-22 months	0.30	0.04
ANTI-19A, 6 months	0.15	0.04
ANTI-19A, 11-12 months	0.23	0.03
ANTI-19A, 12-13 months	0.95	0.04
ANTI-19A, 18-22 months	0.46	0.06

65. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn2+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	209	142
ANTI-6A, 6 months	0.09	0.03
ANTI-6A, 11-12 months	0.14	0.03
ANTI-6A, 12-13 months	0.50	0.03
ANTI-6A, 18-22 months	0.27	0.05
ANTI-19A, 6 months	0.13	0.04
ANTI-19A, 11-12 months	0.15	0.03
ANTI-19A, 12-13 months	0.89	0.04
ANTI-19A, 18-22 months	0.36	0.06

66. Secondary Outcome

Title	TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN
Description	Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	202	120
OPA-1, 6 months	52.8	4.1
OPA-1, 11-12 months	13.8	4.4
OPA-1, 12-13 months	305.6	4.6
OPA-1, 18-22 months	20.9	4.1
OPA-4, 6 months	845.6	4.6
OPA-4, 11-12 months	78.7	6.0
OPA-4, 12-13 months	1745.7	5.8
OPA-4, 18-22 months	105.1	6.6
OPA-5, 6 months	65.9	4.0
OPA-5, 11-12 months	20.6	4.0
OPA-5, 12-13 months	191.6	4.1
OPA-5, 18-22 months	26.9	4.0
OPA-6B, 6 months	740.6	4.4
OPA-6B, 11-12 months	220.3	5.5
OPA-6B, 12-13 months	736.3	6.1
OPA-6B, 18-22 months	75.0	7.4
OPA-7F, 6 months	3894.8	87.6
OPA-7F, 11-12 months	1960.7	349.0
OPA-7F, 12-13 months	5219.7	436.7
OPA-7F, 18-22 months	2124.5	643.3
OPA-9V, 6 months	2798.0	6.5
OPA-9V, 11-12 months	735.3	19.4
OPA-9V, 12-13 months	3491.2	24.7
OPA-9V, 18-22 months	809.1	73.0
OPA-14, 6 months	1831.3	10.5
OPA-14, 11-12 months	529.4	18.9
OPA-14, 12-13 months	2657.2	14.1
OPA-14, 18-22 months	639.0	45.2
OPA-18C, 6 months	543.3	4.0
OPA-18C, 11-12 months	50.0	4.1
OPA-18C, 12-13 months	1066.1	4.0
OPA-18C, 18-22 months	70.4	4.1
OPA-19F, 6 months	649.6	4.0
OPA-19F, 11-12 months	63.5	4.2
OPA-19F, 12-13 months	1026.0	4.4
OPA-19F, 18-22 months	80.1	4.4
OPA-23F, 6 months	1900.7	7.0
OPA-23F, 11-12 months	457.1	15.9
OPA-23F, 12-13 months	3248.2	21.8
OPA-23F, 18-22 months	398.6	56.4

67. Secondary Outcome

Title	TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN
Description	Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn2+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	205	139
OPA-1, 6 months	38.3	4.1
OPA-1, 11-12 months	9.8	4.6
OPA-1, 12-13 months	256.9	4.2
OPA-1, 18-22 months	13.0	4.2
OPA-4, 6 months	553.0	4.8
OPA-4, 11-12 months	43.4	4.6
OPA-4, 12-13 months	1143.4	4.7
OPA-4, 18-22 months	51.9	6.3
OPA-5, 6 months	48.5	4.0
OPA-5, 11-12 months	15.6	4.1
OPA-5, 12-13 months	145.6	4.1
OPA-5, 18-22 months	21.2	4.0
OPA-6B, 6 months	268.6	4.2
OPA-6B, 11-12 months	121.6	4.8
OPA-6B, 12-13 months	879.1	5.3
OPA-6B, 18-22 months	62.0	7.9
OPA-7F, 6 months	2553.5	59.6
OPA-7F, 11-12 months	1454.9	364.8
OPA-7F, 12-13 months	4863.2	522.2
OPA-7F, 18-22 months	2182.7	856.5
OPA-9V, 6 months	1687.2	5.3
OPA-9V, 11-12 months	509.4	19.3
OPA-9V, 12-13 months	3196.0	24.5
OPA-9V, 18-22 months	700.1	55.9
OPA-14, 6 months	1146.3	7.3
OPA-14, 11-12 months	233.5	22.2
OPA-14, 12-13 months	1724.2	26.2
OPA-14, 18-22 months	463.8	99.2
OPA-18C, 6 months	230.6	4.0
OPA-18C, 11-12 months	28.9	4.1
OPA-18C, 12-13 months	1052.2	4.2
OPA-18C, 18-22 months	84.9	6.2
OPA-19F, 6 months	197.6	4.1
OPA-19F, 11-12 months	30.1	4.2
OPA-19F, 12-13 months	854.6	4.0
OPA-19F, 18-22 months	56.7	4.3
OPA-23F, 6 months	897.1	5.6
OPA-23F, 11-12 months	237.2	17.3
OPA-23F, 12-13 months	2630.7	17.3
OPA-23F, 18-22 months	222.7	43.4

68. Secondary Outcome

Title	TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN
Description	Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	197	119
OPA-6A, 6 months	90.8	4.1
OPA-6A, 11-12 months	70.9	5.2
OPA-6A, 12-13 months	173.8	5.3
OPA-6A, 18-22 months	32.9	8.0
OPA-19A, 6 months	25.2	4.3
OPA-19A, 11-12 months	8.6	4.3
OPA-19A, 12-13 months	145.0	4.3
OPA-19A, 18-22 months	12.2	4.8

69. Secondary Outcome

Title	TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN
Description	Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn2+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	204	137
OPA-6A, 6 months	43.1	4.4
OPA-6A, 11-12 months	59.0	5.1
OPA-6A, 12-13 months	285.9	5.3
OPA-6A, 18-22 months	41.8	10.5
OPA-19A, 6 months	11.9	4.1
OPA-19A, 11-12 months	5.8	4.0
OPA-19A, 12-13 months	78.9	4.1
OPA-19A, 18-22 months	8.5	5.1

70. Secondary Outcome

Title	ANTIBODY CONCENTRATIONS AGAINST PROTEIN D (ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN
Description	ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	Ctrl3+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	209	123
ANTI-PD, 6 months	1869.4	60.5
ANTI-PD, 11-12 months	955.2	62.7
ANTI-PD, 12-13 months	2734.7	61.6
ANTI-PD, 18-22 months	1030.0	65.5

71. Secondary Outcome

Title	ANTIBODY CONCENTRATIONS AGAINST PROTEIN D(ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN
Description	ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn2+1-6W-6M/053 Group	Ctrl2+1-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Measure Participants	209	139
ANTI-PD, 6 months	1062.9	66.1
ANTI-PD, 11-12 months	505.6	62.9
ANTI-PD, 12-13 months	1903.9	68.2
ANTI-PD, 18-22 months	687.7	78.6

72. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	151	101
ANTI-1, 9-13 months	1.96	0.03
ANTI-1, 13-17 months	0.66	0.04
ANTI-1, 14-18 months	2.62	0.04
ANTI-1, 23-27 months	0.59	0.05
ANTI-4, 9-13 months	5.85	0.03
ANTI-4, 13-17 months	1.55	0.03
ANTI-4, 14-18 months	5.45	0.03
ANTI-4, 23-27 months	1.21	0.03
ANTI-5, 9-13 months	2.40	0.04
ANTI-5, 13-17 months	1.19	0.06
ANTI-5, 14-18 months	4.11	0.07
ANTI-5, 23-27 months	1.30	0.13
ANTI-6B, 9-13 months	0.27	0.03
ANTI-6B, 13-17 months	0.49	0.03
ANTI-6B, 14-18 months	1.06	0.03
ANTI-6B, 23-27 months	0.52	0.06
ANTI-7F, 9-13 months	3.61	0.03
ANTI-7F, 13-17 months	2.22	0.03
ANTI-7F, 14-18 months	5.44	0.04
ANTI-7F, 23-27 months	2.08	0.05
ANTI-9V, 9-13 months	1.42	0.03
ANTI-9V, 13-17 months	0.88	0.03
ANTI-9V, 14-18 months	2.81	0.03
ANTI-9V, 23-27 months	1.16	0.03
ANTI-14, 9-13 months	3.81	0.05
ANTI-14, 13-17 months	3.06	0.08
ANTI-14, 14-18 months	8.38	0.10
ANTI-14, 23-27 months	2.91	0.13
ANTI-18C, 9-13 months	10.03	0.03
ANTI-18C, 13-17 months	4.70	0.03
ANTI-18C, 14-18 months	19.87	0.03
ANTI-18C, 23-27 months	5.46	0.04
ANTI-19F, 9-13 months	6.64	0.04
ANTI-19F, 13-17 months	3.41	0.05
ANTI-19F, 14-18 months	11.73	0.06
ANTI-19F, 23-27 months	3.69	0.09
ANTI-23F, 9-13 months	0.55	0.03
ANTI-23F, 13-17 months	0.64	0.04
ANTI-23F, 14-18 months	2.04	0.04
ANTI-23F, 23-27 months	0.80	0.06

73. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	181	143
ANTI-1, 13-19 months	0.73	0.04
ANTI-1, 19-25 months	1.87	0.04
ANTI-1, 21-27 months	0.95	0.04
ANTI-4, 13-19 months	4.64	0.03
ANTI-4, 19-25 months	5.28	0.03
ANTI-4, 21-27 months	2.57	0.03
ANTI-5, 13-19 months	0.77	0.07
ANTI-5, 19-25 months	3.45	0.07
ANTI-5, 21-27 months	2.14	0.08
ANTI-6B, 13-19 months	0.11	0.04
ANTI-6B, 19-25 months	0.69	0.05
ANTI-6B, 21-27 months	0.48	0.06
ANTI-7F, 13-19 months	2.53	0.03
ANTI-7F, 19-25 months	3.95	0.04
ANTI-7F, 21-27 months	2.73	0.05
ANTI-9V, 13-19 months	0.84	0.03
ANTI-9V, 19-25 months	1.60	0.03
ANTI-9V, 21-27 months	1.22	0.03
ANTI-14, 13-19 months	1.07	0.06
ANTI-14, 19-25 months	6.04	0.09
ANTI-14, 21-27 months	3.73	0.21
ANTI-18C, 13-19 months	3.76	0.04
ANTI-18C, 19-25 months	21.27	0.04
ANTI-18C, 21-27 months	12.44	0.04
ANTI-19F, 13-19 months	2.63	0.06
ANTI-19F, 19-25 months	12.10	0.09
ANTI-19F, 21-27 months	8.49	0.11
ANTI-23F, 13-19 months	0.16	0.03
ANTI-23F, 19-25 months	1.27	0.05
ANTI-23F, 21-27 months	0.83	0.05

74. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	151	100
ANTI-6A, 9-13 months	0.11	0.03
ANTI-6A, 13-17 months	0.23	0.03
ANTI-6A, 14.18 months	0.70	0.03
ANTI-6A, 23-27 months	0.33	0.06
ANTI-19A, 9-13 months	0.33	0.04
ANTI-19A, 13-17 months	0.49	0.05
ANTI-19A, 14.18 months	1.98	0.04
ANTI-19A, 23-27 months	0.93	0.08

75. Secondary Outcome

Title	PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN
Description	Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.
Time Frame	At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

Outcome Measure Data

Analysis Population Description

The According-to-Protocol cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	181	143
ANTI-6A, 13-19 months	0.06	0.04
ANTI-6A, 19-25 months	0.32	0.05
ANTI-6A, 21-27 months	0.29	0.06
ANTI-19A, 13-19 months	0.20	0.05
ANTI-19A, 19-25 months	2.61	0.06
ANTI-19A, 21-27 months	1.72	0.07

76. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1846	942	1329
Number (95% Confidence Interval) [Participants per 1000 person-years]	420.645 22.7%	415.560 31.6%	443.411 41.5%

77. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	191	96
Number (95% Confidence Interval) [Participants per 1000 person-years]	510.388 27.6%	590.118 44.8%

78. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	286	106
Number (95% Confidence Interval) [Participants per 1000 person-years]	598.065 32.3%	567.194 43.1%

79. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1846	942	1329
Number (95% Confidence Interval) [Participants per 1000 person-years]	100.550 5.4%	103.008 7.8%	94.946 8.9%

80. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	191	96
Number (95% Confidence Interval) [Participants per 1000 person-years]	78.521 4.2%	132.984 10.1%

81. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	286	106
Number (95% Confidence Interval) [Participants per 1000 person-years]	90.355 4.9%	46.302 3.5%

82. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn3+1-6W-6M/053 Group	10Pn2+1-6W-6M/053 Group	Ctrl-6W-6M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B-thio free vaccine (or HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	1846	942	1329
Number (95% Confidence Interval) [Participants per 1000 person-years]	409.795 22.2%	408.505 31%	430.984 40.3%

83. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn7-11M/053 Group	Ctrl7-11M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	191	96
Number (95% Confidence Interval) [Participants per 1000 person-years]	497.301 26.9%	581.807 44.2%

84. Secondary Outcome

Title	PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN
Description	The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.
Time Frame	Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Outcome Measure Data

Analysis Population Description

The total vaccinated cohort for analysis of AOM/RTI effectiveness included all vaccinated subjects for whom data concerning AOM/RTI effectiveness outcome measures were available.

Arm/Group Title	10Pn12-18M/053 Group	Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Measure Participants	286	106
Number (95% Confidence Interval) [Participants per 1000 person-years]	593.763 32.1%	555.619 42.2%

85. Secondary Outcome

Title	Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated,subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn3+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8427 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10272	10201
Culture confirmed ID	0.046 0%	0.268 0%
Pneumococcal invasive disease (IPD)	0.023 0%	0.210 0%
Vaccine serotypes (vaccine type-IPD)	0.0 0%	0.140 0%
Serotype 4	0.0 0%	0.0 0%
Serotype 6B	0.0 0%	0.058 0%
Serotype 7F	0.0 0%	0.0 0%
Serotype 14	0.0 0%	0.047 0%
Serotype 18C	0.0 0%	0.012 0%
Serotype 19F	0.0 0%	0.012 0%
Serotype 23F	0.0 0%	0.012 0%
Cross-reactive serotypes	0.012 0%	0.047 0%
Serotype 6A	0.0 0%	0.012 0%
Serotype 19A	0.012 0%	0.035 0%
Other pneumococcal serotypes	0.012 0%	0.023 0%
Serotype 3	0.012 0%	0.012 0%
Serotype 12F	0.0 0%	0.012 0%
Serotype 15C	0.0 0%	0.0 0%
H. influenzae ID	0.0 0%	0.012 0%
Non-typeable (NTHI)	0.0 0%	0.012 0%
Other bacteria	0.023 0%	0.058 0%
Neisseria meningitidis	0.023 0%	0.023 0%
Streptococcus pyogenes	0.0 0%	0.023 0%
Moraxella catarrhalis	0.0 0%	0.012 0%

86. Secondary Outcome

Title	Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period.
Description	The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Time Frame	Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Infant Vaccinated cohort, which included all vaccinated subjects in the 10PN-PD-DIT-043 study and vaccinated subjects of 10PN-PD-DIT-053 study who contributed to the effectiveness analysis, with first dose of study vaccine below 7 months of age and assigned to a 3-dose primary vaccination course.

Arm/Group Title	10Pn2+1-6W-6M/043+053 Group	Ctrl-6W-6M/043+053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 9112 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, or 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/053 Group for details on vaccine specifics and administration route in this group.	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) (i.e. 8872 subjects) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) studies and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group descriptions for Ctrl3+1-6W-6M/053 and Ctrl2+1-6W-6M/053 groups for details on vaccine specifics and administration route in this group.
Measure Participants	10053	10201
Culture confirmed ID	0.047 0%	0.268 0%
Pneumococcal invasive disease (IPD)	0.024 0%	0.210 0%
Vaccine serotypes (vaccine type-IPD)	0.012 0%	0.140 0%
Serotype 4	0.0 0%	0.0 0%
Serotype 6B	0.0 0%	0.058 0%
Serotype 7F	0.012 0%	0.0 0%
Serotype 14	0.0 0%	0.047 0%
Serotype 18C	0.0 0%	0.012 0%
Serotype 19F	0.0 0%	0.012 0%
Serotype 23F	0.0 0%	0.012 0%
Cross-reactive serotypes	0.0 0%	0.047 0%
Serotype 6A	0.0 0%	0.012 0%
Serotype 19A	0.0 0%	0.035 0%
Other pneumococcal serotypes	0.012 0%	0.023 0%
Serotype 3	0.012 0%	0.012 0%
Serotype 12F	0.0 0%	0.012 0%
Serotype 15C	0.0 0%	0.0 0%
H. influenzae ID	0.012 0%	0.012 0%
Non-typeable (NTHI)	0.012 0%	0.012 0%
Other bacteria	0.012 0%	0.058 0%
Neisseria meningitidis	0.012 0%	0.023 0%
Streptococcus pyogenes	0.0 0%	0.023 0%
Moraxella catarrhalis	0.0 0%	0.012 0%

Adverse Events

Time Frame	Solicited and unsolicited AEs: 4-day (Days 0-3) and 31-day (Days 0-30) post primary (PRI)/booster (BST) vaccination dose(s); SAEs: from day to study end, Month (M) 18 for 6W-6M groups, M16 for 7-11M groups and M9 for M12-18 groups.
Adverse Event Reporting Description	To avoid inconsistency between the AE reporting and the acute otitis media (AOM) questionnaire filled in by subjects' parent(s)/LAR(s), otitis was not reported as an AE if already reported via the AOM questionnaire.
Arm/Group Title	10Pn3+1-6W-6M/053 Group		10Pn2+1-6W-6M/053 Group		Ctrl3+1-6W-6M/053 Group		Ctrl2+1-6W-6M/053 Group		10Pn7-11M/053 Group		Ctrl7-11M/053 Group		10Pn12-18M/053 Group		Ctrl12-18M/053 Group
Arm/Group Description	Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.		Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
All Cause Mortality
	10Pn3+1-6W-6M/053 Group		10Pn2+1-6W-6M/053 Group		Ctrl3+1-6W-6M/053 Group		Ctrl2+1-6W-6M/053 Group		10Pn7-11M/053 Group		Ctrl7-11M/053 Group		10Pn12-18M/053 Group		Ctrl12-18M/053 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Serious Adverse Events
	10Pn3+1-6W-6M/053 Group		10Pn2+1-6W-6M/053 Group		Ctrl3+1-6W-6M/053 Group		Ctrl2+1-6W-6M/053 Group		10Pn7-11M/053 Group		Ctrl7-11M/053 Group		10Pn12-18M/053 Group		Ctrl12-18M/053 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	163/1849 (8.8%)		96/1316 (7.3%)		77/1069 (7.2%)		74/859 (8.6%)		24/241 (10%)		18/204 (8.8%)		23/368 (6.3%)		14/271 (5.2%)
Blood and lymphatic system disorders
Aplasia pure red cell	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Lymphadenitis	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Cardiac disorders
Cyanosis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pericardial effusion	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Congenital, familial and genetic disorders
Amaurotic familial idiocy	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Patent ductus arteriosus	2/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Ventricular septal defect	1/1849 (0.1%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Combined immunodeficiency	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Craniosynostosis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pyloric stenosis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Coarctation of the aorta	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Krabbe's disease	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Mitochondrial encephalomyopathy	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Gastrointestinal disorders
Diarrhoea	1/1849 (0.1%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Enteritis	2/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Intussusception	2/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Gastroenteritis adenovirus	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Gastroenteritis rotavirus	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		1/368 (0.3%)		1/271 (0.4%)
Gastrooesophageal reflux disease	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Inguinal hernia	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Inguinal hernia strangulated	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Vomiting	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Melaena	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
General disorders
Pyrexia	4/1849 (0.2%)		4/1316 (0.3%)		4/1069 (0.4%)		2/859 (0.2%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Crying	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Developmental delay	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Sudden death	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Immune system disorders
Milk allergy	1/1849 (0.1%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Anaphylactic reaction	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Infections and infestations
Bronchitis	33/1849 (1.8%)		13/1316 (1%)		19/1069 (1.8%)		20/859 (2.3%)		9/241 (3.7%)		5/204 (2.5%)		5/368 (1.4%)		2/271 (0.7%)
Otitis media	22/1849 (1.2%)		7/1316 (0.5%)		9/1069 (0.8%)		13/859 (1.5%)		1/241 (0.4%)		0/204 (0%)		1/368 (0.3%)		2/271 (0.7%)
Bronchiolitis	9/1849 (0.5%)		8/1316 (0.6%)		5/1069 (0.5%)		9/859 (1%)		1/241 (0.4%)		2/204 (1%)		0/368 (0%)		0/271 (0%)
Gastroenteritis	15/1849 (0.8%)		7/1316 (0.5%)		5/1069 (0.5%)		4/859 (0.5%)		3/241 (1.2%)		1/204 (0.5%)		2/368 (0.5%)		1/271 (0.4%)
Laryngitis	12/1849 (0.6%)		6/1316 (0.5%)		4/1069 (0.4%)		7/859 (0.8%)		1/241 (0.4%)		0/204 (0%)		2/368 (0.5%)		0/271 (0%)
Respiratory syncytial virus bronchiolitis	11/1849 (0.6%)		7/1316 (0.5%)		4/1069 (0.4%)		4/859 (0.5%)		1/241 (0.4%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Pneumonia	10/1849 (0.5%)		5/1316 (0.4%)		3/1069 (0.3%)		5/859 (0.6%)		1/241 (0.4%)		1/204 (0.5%)		2/368 (0.5%)		1/271 (0.4%)
Pyelonephritis	10/1849 (0.5%)		7/1316 (0.5%)		2/1069 (0.2%)		2/859 (0.2%)		0/241 (0%)		1/204 (0.5%)		2/368 (0.5%)		1/271 (0.4%)
Upper respiratory tract infection	5/1849 (0.3%)		3/1316 (0.2%)		3/1069 (0.3%)		3/859 (0.3%)		0/241 (0%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Otitis media acute	5/1849 (0.3%)		2/1316 (0.2%)		1/1069 (0.1%)		3/859 (0.3%)		2/241 (0.8%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Sepsis	2/1849 (0.1%)		1/1316 (0.1%)		2/1069 (0.2%)		2/859 (0.2%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Respiratory syncytial virus infection	4/1849 (0.2%)		0/1316 (0%)		0/1069 (0%)		2/859 (0.2%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Urinary tract infection	2/1849 (0.1%)		2/1316 (0.2%)		1/1069 (0.1%)		1/859 (0.1%)		0/241 (0%)		1/204 (0.5%)		1/368 (0.3%)		0/271 (0%)
Infection	2/1849 (0.1%)		1/1316 (0.1%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pneumonia respiratory syncytial viral	1/1849 (0.1%)		2/1316 (0.2%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Tonsillitis	2/1849 (0.1%)		2/1316 (0.2%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Adenovirus infection	2/1849 (0.1%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Bacterial infection	0/1849 (0%)		0/1316 (0%)		2/1069 (0.2%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pneumococcal sepsis	0/1849 (0%)		1/1316 (0.1%)		2/1069 (0.2%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Anal abscess	1/1849 (0.1%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Enterovirus infection	2/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
H1N1 influenza	2/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Influenza	1/1849 (0.1%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Respiratory syncytial virus bronchitis	0/1849 (0%)		7/1316 (0.5%)		2/1069 (0.2%)		4/859 (0.5%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Abscess neck	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Bacterial sepsis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Croup infectious	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Ear infection	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Groin abscess	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Herpes zoster	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Laryngitis viral	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Laryngomalcia	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Lymph gland infection	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Meningococcal sepsis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pharyngitis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pneumococcal bacteraemia	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pneumococcal infection	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pneumonia bacterial	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Respiratory tract infection viral	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Staphylococcal sepsis	1/1849 (0.1%)		1/1316 (0.1%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Streptococcal infection	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Tracheitis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Viral infection	1/1849 (0.1%)		3/1316 (0.2%)		4/1069 (0.4%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Pyelonephritis acute	4/1849 (0.2%)		0/1316 (0%)		1/1069 (0.1%)		3/859 (0.3%)		0/241 (0%)		2/204 (1%)		0/368 (0%)		0/271 (0%)
Streptococcal sepsis	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Varicella	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Cystitis	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Eczema infected	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Exanthema subitum	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Gastroenteritis norovirus	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Hand-foot-and-mouth disease	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Impetigo	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Lobar pneumonia	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Mastoiditis	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Osteomyelitis	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Parainfluenzae virus infection	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Septic arthritis streptococcal	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Diarrhoea infectious	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Escherichia sepsis	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Otitis media fungal	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Pneumonia viral	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Respiratory tract infection	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Roseola	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Rotavirus infection	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Gastroenteritis viral	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		2/368 (0.5%)		0/271 (0%)
Cellulitis	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Cellulitis orbital	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Viral upper respiratory tract infection	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Injury, poisoning and procedural complications
Femur fracture	2/1849 (0.1%)		1/1316 (0.1%)		2/1069 (0.2%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Foreign body	1/1849 (0.1%)		2/1316 (0.2%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Thermal burn	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		1/859 (0.1%)		1/241 (0.4%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Tibia fracture	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Contusion	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Electric shock	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Joint dislocation	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Poisoning	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Concussion	3/1849 (0.2%)		2/1316 (0.2%)		0/1069 (0%)		2/859 (0.2%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Burns second degree	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Chemical poisoning	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Skull fracture	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Accidental drug intake by child	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Accidental poisoning	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		1/368 (0.3%)		0/271 (0%)
Investigations
Cardiac murmur	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Metabolism and nutrition disorders
Type 1 diabetes mellitus	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Weight gain poor	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Dehydration	0/1849 (0%)		2/1316 (0.2%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Hypoglycaemia	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Musculoskeletal and connective tissue disorders
Juvenile arthritis	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Neck pain	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Nervous system disorders
Febrile convulsion	5/1849 (0.3%)		6/1316 (0.5%)		1/1069 (0.1%)		2/859 (0.2%)		0/241 (0%)		1/204 (0.5%)		2/368 (0.5%)		1/271 (0.4%)
Convulsion	5/1849 (0.3%)		2/1316 (0.2%)		2/1069 (0.2%)		1/859 (0.1%)		1/241 (0.4%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Epilepsy	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		1/241 (0.4%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Hyperreflexia	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Loss of consciousness	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Nervous system disorder	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Petit mal epilepsy	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Altered state of consciousness	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Balance disorder	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Cerebral infarction	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Cognitive disorder	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Dysarthria	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Psychiatric disorders
Breath holding	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Confusional state	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Respiratory, thoracic and mediastinal disorders
Asthma	4/1849 (0.2%)		2/1316 (0.2%)		4/1069 (0.4%)		3/859 (0.3%)		4/241 (1.7%)		1/204 (0.5%)		4/368 (1.1%)		2/271 (0.7%)
Dyspnoea	0/1849 (0%)		2/1316 (0.2%)		1/1069 (0.1%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Apnoea	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Cough	0/1849 (0%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		1/204 (0.5%)		0/368 (0%)		0/271 (0%)
Skin and subcutaneous tissue disorders
Urticaria	0/1849 (0%)		0/1316 (0%)		1/1069 (0.1%)		1/859 (0.1%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		1/271 (0.4%)
Erythema	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Subcutaneous abscess	1/1849 (0.1%)		0/1316 (0%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Eczema nummular	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Vascular disorders
Hypertension	0/1849 (0%)		1/1316 (0.1%)		0/1069 (0%)		0/859 (0%)		0/241 (0%)		0/204 (0%)		0/368 (0%)		0/271 (0%)
Other (Not Including Serious) Adverse Events
	10Pn3+1-6W-6M/053 Group		10Pn2+1-6W-6M/053 Group		Ctrl3+1-6W-6M/053 Group		Ctrl2+1-6W-6M/053 Group		10Pn7-11M/053 Group		Ctrl7-11M/053 Group		10Pn12-18M/053 Group		Ctrl12-18M/053 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1840/1849 (99.5%)		1295/1316 (98.4%)		1038/1069 (97.1%)		805/859 (93.7%)		232/241 (96.3%)		193/204 (94.6%)		354/368 (96.2%)		254/271 (93.7%)
Gastrointestinal disorders
Diarrhoea	140/1849 (7.6%)	160	78/1316 (5.9%)	86	75/1069 (7%)	84	52/859 (6.1%)	58	22/241 (9.1%)	27	17/204 (8.3%)	19	26/368 (7.1%)	28	25/271 (9.2%)	28
Teething	66/1849 (3.6%)	83	40/1316 (3%)	45	61/1069 (5.7%)	70	34/859 (4%)	39	11/241 (4.6%)	15	21/204 (10.3%)	21	0/368 (0%)	0	0/271 (0%)	0
Vomiting	0/1849 (0%)	0	0/1316 (0%)	0	0/1069 (0%)	0	0/859 (0%)	0	12/241 (5%)	13	7/204 (3.4%)	7	0/368 (0%)	0	0/271 (0%)	0
General disorders
Injection site induration	419/1849 (22.7%)	720	239/1316 (18.2%)	340	71/1069 (6.6%)	89	29/859 (3.4%)	34	30/241 (12.4%)	47	5/204 (2.5%)	6	45/368 (12.2%)	52	2/271 (0.7%)	2
Pain	1399/1849 (75.7%)	2898	983/1316 (74.7%)	1830	396/1069 (37%)	614	275/859 (32%)	374	176/241 (73%)	351	76/204 (37.3%)	111	301/368 (81.8%)	463	116/271 (42.8%)	143
Pyrexia	1030/1849 (55.7%)	1621	688/1316 (52.3%)	1062	377/1069 (35.3%)	483	261/859 (30.4%)	334	115/241 (47.7%)	154	68/204 (33.3%)	77	119/368 (32.3%)	143	62/271 (22.9%)	70
Swelling	1257/1849 (68%)	2716	878/1316 (66.7%)	1594	382/1069 (35.7%)	575	205/859 (23.9%)	262	154/241 (63.9%)	290	50/204 (24.5%)	68	209/368 (56.8%)	290	42/271 (15.5%)	51
Infections and infestations
Nasopharyngitis	107/1849 (5.8%)	127	49/1316 (3.7%)	59	64/1069 (6%)	87	64/859 (7.5%)	74	18/241 (7.5%)	19	11/204 (5.4%)	14	0/368 (0%)	0	0/271 (0%)	0
Otitis media	69/1849 (3.7%)	80	32/1316 (2.4%)	34	57/1069 (5.3%)	65	24/859 (2.8%)	24	25/241 (10.4%)	26	19/204 (9.3%)	23	25/368 (6.8%)	29	22/271 (8.1%)	23
Rhinitis	147/1849 (8%)	178	74/1316 (5.6%)	88	105/1069 (9.8%)	123	72/859 (8.4%)	83	21/241 (8.7%)	25	36/204 (17.6%)	43	29/368 (7.9%)	33	25/271 (9.2%)	29
Upper respiratory tract infection	233/1849 (12.6%)	291	109/1316 (8.3%)	122	131/1069 (12.3%)	161	45/859 (5.2%)	53	38/241 (15.8%)	46	50/204 (24.5%)	67	36/368 (9.8%)	37	40/271 (14.8%)	47
Gastroenteritis	0/1849 (0%)	0	0/1316 (0%)	0	0/1069 (0%)	0	0/859 (0%)	0	9/241 (3.7%)	9	12/204 (5.9%)	13	0/368 (0%)	0	0/271 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	1103/1849 (59.7%)	1832	713/1316 (54.2%)	1072	527/1069 (49.3%)	828	356/859 (41.4%)	483	153/241 (63.5%)	217	105/204 (51.5%)	159	191/368 (51.9%)	238	118/271 (43.5%)	140
Nervous system disorders
Somnolence	1493/1849 (80.7%)	3305	1024/1316 (77.8%)	1876	723/1069 (67.6%)	1394	539/859 (62.7%)	887	165/241 (68.5%)	286	101/204 (49.5%)	161	214/368 (58.2%)	281	118/271 (43.5%)	145
Psychiatric disorders
Irritability	1761/1849 (95.2%)	4864	1204/1316 (91.5%)	2592	914/1069 (85.5%)	2134	688/859 (80.1%)	1304	207/241 (85.9%)	428	152/204 (74.5%)	272	283/368 (76.9%)	407	142/271 (52.4%)	181
Respiratory, thoracic and mediastinal disorders
Cough	0/1849 (0%)	0	0/1316 (0%)	0	0/1069 (0%)	0	0/859 (0%)	0	9/241 (3.7%)	9	11/204 (5.4%)	13	14/368 (3.8%)	16	15/271 (5.5%)	16
Skin and subcutaneous tissue disorders
Erythema	1522/1849 (82.3%)	3821	1042/1316 (79.2%)	2077	584/1069 (54.6%)	1188	397/859 (46.2%)	665	182/241 (75.5%)	369	89/204 (43.6%)	162	265/368 (72%)	398	130/271 (48%)	179

Limitations/Caveats

Number allocation errors were identified for 3 subjects after Dose 1, which GSK assessed as not having significant impact. Lower & upper respiratory tract infections endpoint results are not presented, being uninterpretable due to low sample size.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.