Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01453998
• Collaborator: (none)
• Enrollment: 657
• Locations: 16
• Arms: 3
• Actual Duration (Months): 13
• Patients Per Site: 41.1
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Hepatitis B; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Poliomyelitis	Biological: Infanrix hexa; Biological: Prevenar 13; Biological: GSK217744	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 657 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
• Actual Study Start Date: Oct 14, 2011
• Actual Primary Completion Date: Nov 12, 2012
• Actual Study Completion Date: Nov 12, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK217744 Group 1 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Biological: Infanrix hexa; Single dose, licensed formulation, intramuscular into right thigh; Other Names: DTPa-HBV-IPV/Hib ; Biological: Prevenar 13; Single co-administered dose, intramuscular into left thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine ; Biological: GSK217744; Single dose, investigational formulation A or B, intramuscular into right thigh
Experimental: GSK217744 Group 2 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Biological: Infanrix hexa; Single dose, licensed formulation, intramuscular into right thigh; Other Names: DTPa-HBV-IPV/Hib ; Biological: Prevenar 13; Single co-administered dose, intramuscular into left thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine ; Biological: GSK217744; Single dose, investigational formulation A or B, intramuscular into right thigh
Active Comparator: Infanrix hexa Group Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Biological: Infanrix hexa; Single dose, licensed formulation, intramuscular into right thigh; Other Names: DTPa-HBV-IPV/Hib ; Biological: Prevenar 13; Single co-administered dose, intramuscular into left thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

2. Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

3. Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

4. Number of Seroprotected Subjects Against Anti-HBs Antigens [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

5. Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

6. Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

7. Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

8. Number of Seroprotected Subjects for Anti-PRP [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

9. Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

10. Concentrations for Anti-PT, Anti-FHA and Anti-PRN [1 month post booster vaccination (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

Secondary Outcome Measures

1. Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

2. Concentrations for Anti-D and Anti-T Antibodies [Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

3. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

4. Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

5. Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

   Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

6. Concentrations for Anti-PT, Anti-FHA and Anti-PRN [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

   Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

7. Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

   A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

8. Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

   A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

9. Anti-Hepatitis B (Anti-HBs) Antibody Concentrations [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))]

   Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

10. Anti-HBs Antibody Concentrations [1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

11. Anti-Hepatitis B (Anti-HBs) Antibody Concentration [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

12. Anti-HBs Antibody Concentrations [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.

13. Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

14. Number of Seroprotected Subjects Against Anti-HBs Antigens [Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)]

    A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

15. Concentrations for Anti-poliovirus Types 1, 2, 3 [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

16. Concentration for Anti-poliovirus Types 1, 2, 3 [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

17. Concentrations for Anti-poliovirus Types 1, 2 and 3 [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

18. Concentration for Anti-poliovirus Type 1, 2 and 3 [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.

19. Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

20. Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

    A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

21. Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

22. Concentrations for Anti-PRP Antibodies [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

23. Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

24. Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.

25. Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

26. Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

    A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).

27. Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) [Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)]

    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

28. Number of Seroprotected Subjects for Anti-PRP [Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)]

    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

29. Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

30. Concentrations for Anti-PNE Antibodies [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

31. Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

    A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

32. Number of Seropositive Subjects for Anti-PNE Serotypes [1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

    A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

33. Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) [1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)]

    Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

34. Number of Subjects With Booster Response to Anti-pertussis Antigens [1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)]

    Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration

35. Number of Subjects Reporting Any Solicited Local Symptoms [During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)]

    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

36. Number of Subjects Reporting Any Solicited Local Symptom [During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)]

    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

37. Number of Subjects Reporting Any Solicited General Symptoms [During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)]

    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

38. Number of Subjects Reporting Any Solicited General Symptom [During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)]

    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

39. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)]

    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

40. Number of Subjects Reporting Any Unsolicited AEs [Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)]

    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

41. Number of Subjects Reporting Any Serious Adverse Events (SAEs) [During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

42. Number of Subjects Reporting Any SAEs [During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 15 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.

• A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.

• Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).

• Written informed consent obtained from the parent(s)/LAR(s) of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Child in care.

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

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.

• Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884).

• Serious chronic illness.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• History of any neurological disorders or seizures.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.

• Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing.

• Anaphylactic or other hypersensitivity reaction.

• Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.

• Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause.

• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.

• Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.

• Seizures with or without fever occurring within 3 days of vaccination.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0° on rectal setting.

• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Santo Domingo, Distrito Nacional		Dominican Republic
2	GSK Investigational Site	Santo Domingo		Dominican Republic
3	GSK Investigational Site	Espoo		Finland	02100
4	GSK Investigational Site	Helsinki		Finland	00100
5	GSK Investigational Site	Helsinki		Finland	00930
6	GSK Investigational Site	Jarvenpaa		Finland	04400
7	GSK Investigational Site	Kokkola		Finland	67100
8	GSK Investigational Site	Kuopio		Finland	70210
9	GSK Investigational Site	Lahti		Finland	15140
10	GSK Investigational Site	Oulu		Finland	90220
11	GSK Investigational Site	Pori		Finland	28100
12	GSK Investigational Site	Seinajoki		Finland	60100
13	GSK Investigational Site	Tampere		Finland	33100
14	GSK Investigational Site	Turku		Finland	20520
15	GSK Investigational Site	Vantaa		Finland	01300
16	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

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01453998
• Other Study ID Numbers: 114843; 2011-000876-33
• First Posted: Oct 18, 2011
• Last Update Posted: Jul 17, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa vaccine.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Period Title: Before Protocol Amendment 2
STARTED	85	88	99
COMPLETED	85	88	99
NOT COMPLETED	0	0	0
Period Title: Before Protocol Amendment 2
STARTED	131	130	124
COMPLETED	130	130	124
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group	Total
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Total of all reporting groups
Overall Participants	216	218	223	657
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	12.9 (0.7)	13.0 (0.7)	13.0 (0.8)	12.97 (0.71)
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	14.1 (0.6)	13.9 (0.6)	14.0 (0.6)	14.00 (0.61)
Sex: Female, Male (Count of Participants)
Female	47 21.8%	49 22.5%	38 17%	134 20.4%
Male	38 17.6%	39 17.9%	61 27.4%	138 21%
Sex: Female, Male (Count of Participants)
Female	61 28.2%	76 34.9%	53 23.8%	190 28.9%
Male	70 32.4%	54 24.8%	71 31.8%	195 29.7%
Race/Ethnicity, Customized (Count of Participants)
White - Arabic / north African heritage	2 0.9%	1 0.5%	3 1.3%	6 0.9%
White - Caucasian / European heritage	79 36.6%	83 38.1%	91 40.8%	253 38.5%
Other: Mixed	4 1.9%	4 1.8%	5 2.2%	13 2%
Race/Ethnicity, Customized (Count of Participants)
African heritage / African American	1 0.5%	0 0%	1 0.4%	2 0.3%
White - Arabic / north African heritage	0 0%	0 0%	3 1.3%	3 0.5%
White - caucasian / European heritage	49 22.7%	46 21.1%	39 17.5%	134 20.4%
Other: Mixed	81 37.5%	84 38.5%	81 36.3%	246 37.4%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Anti-D, POST	81 37.5%	82 37.6%	90 40.4%
Anti-T, POST	81 37.5%	82 37.6%	90 40.4%

2. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	118
Anti-D, POST	123 56.9%	122 56%	118 52.9%
Anti-T, POST	123 56.9%	122 56%	118 52.9%

3. Primary Outcome

Title	Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
Description	A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	79	79	84
Count of Participants [Participants]	78 36.1%	78 35.8%	84 37.7%

4. Primary Outcome

Title	Number of Seroprotected Subjects Against Anti-HBs Antigens
Description	A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	115	115
Count of Participants [Participants]	121 56%	113 51.8%	114 51.1%

5. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
Description	A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	77	72	85
Anti-Polio 1, POST	76 35.2%	72 33%	85 38.1%
Anti-Polio 2, POST	62 28.7%	60 27.5%	76 34.1%
Anti-Polio 3, POST	64 29.6%	63 28.9%	71 31.8%

6. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
Description	A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	113	107	103
Anti-Polio 1, POST	111 51.4%	107 49.1%	102 45.7%
Anti-Polio 2, POST	96 44.4%	96 44%	87 39%
Anti-Polio 3, POST	113 52.3%	103 47.2%	98 43.9%

7. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Description	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Count of Participants [Participants]	81 37.5%	82 37.6%	90 40.4%

8. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-PRP
Description	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	118
Count of Participants [Participants]	122 56.5%	122 56%	117 52.5%

9. Primary Outcome

Title	Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Anti-PT, POST	76.1	74.3	96.0
Anti-FHA, POST	393.7	372.4	423.0
Anti-PRN, POST	213.0	180.0	372.9

10. Primary Outcome

Title	Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time Frame	1 month post booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	117
Anti-PT, POST	92.4	93.6	132.6
Anti-FHA, POST	467.3	446.2	582.9
Anti-PRN, POST	253.2	181.0	401.1

11. Secondary Outcome

Title	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame	Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Anti-D, POST	5.652	5.494	6.772
Anti-T, POST	5.015	5.034	5.571
Anti-D, PRE	0.357	0.445	0.401
Anti-T, PRE	0.358	0.362	0.394

12. Secondary Outcome

Title	Concentrations for Anti-D and Anti-T Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame	Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	118
Anti-D, POST	6.327	5.452	7.192
Anti-T, POST	5.986	5.316	5.993
Anti-D, PRE	0.247	0.278	0.304
Anti-T, PRE	0.364	0.332	0.331

13. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Anti-D, PRE	78 36.1%	80 36.7%	84 37.7%
Anti-T, PRE	76 35.2%	78 35.8%	85 38.1%

14. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	117
Anti-D, PRE	107 49.5%	114 52.3%	104 46.6%
Anti-T, PRE	116 53.7%	114 52.3%	111 49.8%

15. Secondary Outcome

Title	Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	89
Anti-PT, PRE	10.5	9.5	12.7
Anti-FHA, PRE	41.7	36.9	47.1
Anti-PRN, PRE	12.8	10.8	18.2

16. Secondary Outcome

Title	Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	117
Anti-PT, PRE	8.3	7.9	9.9
Anti-FHA, PRE	37.6	34.0	45.7
Anti-PRN, PRE	11.6	9.7	15.6

17. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Description	A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Anti-PT, POST	79 36.6%	81 37.2%	89 39.9%
Anti-FHA, POST	81 37.5%	82 37.6%	90 40.4%
Anti-PRN, POST	81 37.5%	81 37.2%	89 39.9%

18. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
Description	A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	117
Anti-PT, POST	118 54.6%	121 55.5%	116 52%
Anti-FHA, POST	123 56.9%	122 56%	117 52.5%
Anti-PRN, POST	122 56.5%	122 56%	117 52.5%

19. Secondary Outcome

Title	Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	79	79	84
Geometric Mean (95% Confidence Interval) [mIU/mL]	2233.3	2026.3	2685.7

20. Secondary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time Frame	1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	115	115
Geometric Mean (95% Confidence Interval) [mIU/mL]	2229.3	1729.8	3711.4

21. Secondary Outcome

Title	Anti-Hepatitis B (Anti-HBs) Antibody Concentration
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	74	79	84
Geometric Mean (95% Confidence Interval) [mIU/mL]	130.3	124.4	166.4

22. Secondary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	120	119	115
Geometric Mean (95% Confidence Interval) [mIU/mL]	94.9	61.8	125.9

23. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
Description	A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	74	79	84
Count of Participants [Participants]	68 31.5%	74 33.9%	78 35%

24. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-HBs Antigens
Description	A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time Frame	Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	120	119	115
Count of Participants [Participants]	108 50%	100 45.9%	106 47.5%

25. Secondary Outcome

Title	Concentrations for Anti-poliovirus Types 1, 2, 3
Description	Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	73	74	80
Anti-Polio 1, PRE	18.2	17.8	22.4
Anti-Polio 2, PRE	12.7	17.1	16.6
Anti-Polio, 3 PRE	24.7	16.8	26.6

26. Secondary Outcome

Title	Concentration for Anti-poliovirus Types 1, 2, 3
Description	Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	77	72	85
Anti-Polio 1, POST	572.9	558.3	902.1
Anti-Polio 2, POST	629.7	668.7	1184.9
Anti-Polio 3, POST	1147.5	614.0	1120.7

27. Secondary Outcome

Title	Concentrations for Anti-poliovirus Types 1, 2 and 3
Description	Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	113	107	103
Anti-Polio 1, POST	1121.0	1099.6	1386.2
Anti-Polio 2, POST	1485.3	1215.6	1537.2
Anti-Polio 3, POST	1851.2	1960.4	2376.4

28. Secondary Outcome

Title	Concentration for Anti-poliovirus Type 1, 2 and 3
Description	Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	108	109	104
Anti-Polio 1, PRE	53.5	50.7	70.8
Anti-Polio 2, PRE	76.6	55.0	82.7
Anti-Polio, 3 PRE	67.8	73.8	93.9

29. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
Description	A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	73	74	80
Anti-Polio 1, PRE	50 23.1%	54 24.8%	56 25.1%
Anti-Polio 2, PRE	38 17.6%	44 20.2%	44 19.7%
Anti-Polio, 3 PRE	51 23.6%	43 19.7%	61 27.4%

30. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
Description	A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	108	109	104
Anti-Polio 1, PRE	95 44%	91 41.7%	92 41.3%
Anti-Polio 2, PRE	78 36.1%	81 37.2%	74 33.2%
Anti-Polio, 3 PRE	96 44.4%	99 45.4%	91 40.8%

31. Secondary Outcome

Title	Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	90
Geometric Mean (95% Confidence Interval) [µg /mL]	12.765	15.904	17.099

32. Secondary Outcome

Title	Concentrations for Anti-PRP Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	122	118
Geometric Mean (95% Confidence Interval) [µg /mL]	21.462	15.903	17.429

33. Secondary Outcome

Title	Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	89
Geometric Mean (95% Confidence Interval) [µg /mL]	0.173	0.175	0.236

34. Secondary Outcome

Title	Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	117
Geometric Mean (90% Confidence Interval) [µg /mL]	0.328	0.288	0.334

35. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Description	A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	89
Anti-PT, PRE	68 31.5%	65 29.8%	78 35%
Anti-FHA, PRE	81 37.5%	81 37.2%	88 39.5%
Anti-PRN, PRE	68 31.5%	69 31.7%	83 37.2%

36. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
Description	A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	117
Anti-PT, PRE	95 44%	94 43.1%	97 43.5%
Anti-FHA, PRE	122 56.5%	117 53.7%	116 52%
Anti-PRN, PRE	98 45.4%	92 42.2%	105 47.1%

37. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Description	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	89
Count of Participants [Participants]	41 19%	45 20.6%	52 23.3%

38. Secondary Outcome

Title	Number of Seroprotected Subjects for Anti-PRP
Description	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame	Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	117
Count of Participants [Participants]	92 42.6%	78 35.8%	81 36.3%

39. Secondary Outcome

Title	Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	50	50	53
Anti- PNE 1	2.07	2.16	2.27
Anti- PNE 3	0.76	0.87	0.88
Anti- PNE 4	1.87	1.83	2.14
Anti- PNE 5	1.18	1.10	1.21
Anti- PNE 6A	7.71	6.92	8.63
Anti- PNE 6B	4.24	4.21	4.58
Anti- PNE 7F	3.27	3.42	4.27
Anti- PNE 9V	1.68	1.52	1.63
Anti- PNE 14	8.22	8.80	8.97
Anti- PNE 18C	1.50	1.63	1.64
Anti- PNE 19A	7.00	8.05	6.70
Anti- PNE 19F	7.15	7.34	6.72
Anti- PNE 23F	3.74	4.54	3.94

40. Secondary Outcome

Title	Concentrations for Anti-PNE Antibodies
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	23	21	20
Anti- PNE 1	2.54	2.47	3.47
Anti- PNE 3	0.76	0.82	0.92
Anti-PNE 4	2.03	2.10	2.57
Anti-PNE 5	1.26	1.24	1.29
Anti-PNE 6A	10.64	7.67	7.47
Anti-PNE 6B	5.04	4.56	6.62
Anti-PNE 7F	4.20	3.97	4.67
Anti-PNE 9V	2.20	1.42	1.85
Anti-PNE 14	7.47	8.12	9.28
Anti-PNE 18C	1.80	1.52	2.09
Anti-PNE 19A	8.79	6.22	9.10
Anti-PNE 19F	8.09	7.11	5.56
Anti-PNE 23F	5.31	4.00	5.82

41. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
Description	A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	50	50	53
Anti- PNE 1	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 3	40 18.5%	43 19.7%	43 19.3%
Anti- PNE 4	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 5	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 6A	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 6B	50 23.1%	49 22.5%	53 23.8%
Anti- PNE 7F	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 9V	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 14	49 22.7%	50 22.9%	53 23.8%
Anti- PNE 18C	49 22.7%	50 22.9%	53 23.8%
Anti- PNE 19A	49 22.7%	50 22.9%	53 23.8%
Anti- PNE 19F	50 23.1%	50 22.9%	53 23.8%
Anti- PNE 23F	50 23.1%	47 21.6%	52 23.3%

42. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PNE Serotypes
Description	A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	23	21	20
Anti- PNE 1	23 10.6%	21 9.6%	20 9%
Anti- PNE 3	21 9.7%	18 8.3%	16 7.2%
Anti-PNE 4	23 10.6%	21 9.6%	20 9%
Anti-PNE 5	23 10.6%	21 9.6%	20 9%
Anti-PNE 6A	23 10.6%	21 9.6%	20 9%
Anti-PNE 6B	23 10.6%	21 9.6%	20 9%
Anti-PNE 7F	23 10.6%	21 9.6%	20 9%
Anti-PNE 9V	23 10.6%	21 9.6%	20 9%
Anti-PNE 14	23 10.6%	21 9.6%	20 9%
Anti-PNE 18C	23 10.6%	21 9.6%	20 9%
Anti-PNE 19A	23 10.6%	21 9.6%	19 8.5%
Anti-PNE 19F	23 10.6%	21 9.6%	20 9%
Anti-PNE 23F	23 10.6%	21 9.6%	20 9%

43. Secondary Outcome

Title	Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
Description	Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time Frame	1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	81	82	88
Anti-PT	72 33.3%	77 35.3%	86 38.6%
Anti-FHA	79 36.6%	81 37.2%	87 39%
Anti-PRN	81 37.5%	80 36.7%	87 39%

44. Secondary Outcome

Title	Number of Subjects With Booster Response to Anti-pertussis Antigens
Description	Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time Frame	1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	123	121	116
Anti-PT	118	119	110
Anti-FHA	120	115	113
Anti-PRN	121	120	115

45. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited Local Symptoms
Description	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	85	88	99
Any pain	56 25.9%	67 30.7%	63 28.3%
Any redness	55 25.5%	56 25.7%	59 26.5%
Any swelling	45 20.8%	43 19.7%	48 21.5%

46. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited Local Symptom
Description	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	131	130	124
Any pain	76 35.2%	66 30.3%	64 28.7%
Any redness	47 21.8%	36 16.5%	40 17.9%
Any swelling	43 19.9%	34 15.6%	38 17%

47. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited General Symptoms
Description	Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	85	88	99
Any drowsiness	54 25%	47 21.6%	47 21.1%
Any irritability/fussiness	69 31.9%	73 33.5%	74 33.2%
Any loss of appetite	43 19.9%	45 20.6%	46 20.6%
Any fever	42 19.4%	41 18.8%	37 16.6%

48. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited General Symptom
Description	Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	131	130	124
Any drowsiness	52 24.1%	40 18.3%	40 17.9%
Any irritability/fussiness	66 30.6%	58 26.6%	62 27.8%
Any loss of appetite	42 19.4%	37 17%	34 15.2%
Any fever	58 26.9%	50 22.9%	52 23.3%

49. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time Frame	Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	85	88	99
Count of Participants [Participants]	42 19.4%	39 17.9%	67 30%

50. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited AEs
Description	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time Frame	Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	131	130	124
Count of Participants [Participants]	38 17.6%	27 12.4%	31 13.9%

51. Secondary Outcome

Title	Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time Frame	During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	85	88	99
Count of Participants [Participants]	0 0%	0 0%	0 0%

52. Secondary Outcome

Title	Number of Subjects Reporting Any SAEs
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time Frame	During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
Measure Participants	131	130	124
Count of Participants [Participants]	0 0%	2 0.9%	0 0%

Adverse Events

Time Frame	Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
Arm/Group Title	GSK217744 Group 1(Before Protocol Amendment2)		GSK217744 Group 2(Before Protocol Amendment2)		Infanrix Hexa Group(Before Protocol Amendment2)		GSK217744 Group 1(After Protocol Amendment2)		GSK217744 Group 2(After Protocol Amendment2)		Infanrix Hexa Group(After Protocol Amendment2)
Arm/Group Description	Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.		Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.		Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.		Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.		Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.		Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively
All Cause Mortality
	GSK217744 Group 1(Before Protocol Amendment2)		GSK217744 Group 2(Before Protocol Amendment2)		Infanrix Hexa Group(Before Protocol Amendment2)		GSK217744 Group 1(After Protocol Amendment2)		GSK217744 Group 2(After Protocol Amendment2)		Infanrix Hexa Group(After Protocol Amendment2)
	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	0/85 (0%)		0/88 (0%)		0/99 (0%)		0/131 (0%)		0/130 (0%)		0/124 (0%)
Serious Adverse Events
	GSK217744 Group 1(Before Protocol Amendment2)		GSK217744 Group 2(Before Protocol Amendment2)		Infanrix Hexa Group(Before Protocol Amendment2)		GSK217744 Group 1(After Protocol Amendment2)		GSK217744 Group 2(After Protocol Amendment2)		Infanrix Hexa Group(After Protocol Amendment2)
	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	0/85 (0%)		0/88 (0%)		0/99 (0%)		0/131 (0%)		2/130 (1.5%)		0/124 (0%)
Infections and infestations
Pneumonia	0/85 (0%)		0/88 (0%)		0/99 (0%)		0/131 (0%)		2/130 (1.5%)		0/124 (0%)
Metabolism and nutrition disorders
Dehydration	0/85 (0%)		0/88 (0%)		0/99 (0%)		0/131 (0%)		1/130 (0.8%)		0/124 (0%)
Other (Not Including Serious) Adverse Events
	GSK217744 Group 1(Before Protocol Amendment2)		GSK217744 Group 2(Before Protocol Amendment2)		Infanrix Hexa Group(Before Protocol Amendment2)		GSK217744 Group 1(After Protocol Amendment2)		GSK217744 Group 2(After Protocol Amendment2)		Infanrix Hexa Group(After Protocol Amendment2)
	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	85/85 (100%)		85/88 (96.6%)		96/99 (97%)		118/131 (90.1%)		103/130 (79.2%)		104/124 (83.9%)
Gastrointestinal disorders
Diarrhoea	5/85 (5.9%)		6/88 (6.8%)		4/99 (4%)		2/131 (1.5%)		2/130 (1.5%)		4/124 (3.2%)
General disorders
Injection site induration	7/85 (8.2%)		3/88 (3.4%)		5/99 (5.1%)		4/131 (3.1%)		0/130 (0%)		0/124 (0%)
Pyrexia	44/85 (51.8%)		45/88 (51.1%)		39/99 (39.4%)		59/131 (45%)		51/130 (39.2%)		52/124 (41.9%)
Pain	56/85 (65.9%)		67/88 (76.1%)		63/99 (63.6%)		76/131 (58%)		66/130 (50.8%)		64/124 (51.6%)
Swelling	45/85 (52.9%)		43/88 (48.9%)		48/99 (48.5%)		43/131 (32.8%)		34/130 (26.2%)		38/124 (30.6%)
Infections and infestations
Conjunctivitis	3/85 (3.5%)		1/88 (1.1%)		7/99 (7.1%)		0/131 (0%)		0/130 (0%)		0/124 (0%)
Nasopharyngitis	4/85 (4.7%)		2/88 (2.3%)		5/99 (5.1%)		13/131 (9.9%)		9/130 (6.9%)		8/124 (6.5%)
Otitis media	6/85 (7.1%)		11/88 (12.5%)		11/99 (11.1%)		3/131 (2.3%)		3/130 (2.3%)		2/124 (1.6%)
Upper respiratory tract infection	6/85 (7.1%)		7/88 (8%)		9/99 (9.1%)		1/131 (0.8%)		1/130 (0.8%)		4/124 (3.2%)
Gastroenteritis	2/85 (2.4%)		2/88 (2.3%)		5/99 (5.1%)		1/131 (0.8%)		1/130 (0.8%)		1/124 (0.8%)
Metabolism and nutrition disorders
Decreased appetite	43/85 (50.6%)		45/88 (51.1%)		46/99 (46.5%)		42/131 (32.1%)		37/130 (28.5%)		34/124 (27.4%)
Nervous system disorders
Somnolence	54/85 (63.5%)		47/88 (53.4%)		47/99 (47.5%)		52/131 (39.7%)		40/130 (30.8%)		40/124 (32.3%)
Psychiatric disorders
Irritability	69/85 (81.2%)		73/88 (83%)		74/99 (74.7%)		66/131 (50.4%)		58/130 (44.6%)		62/124 (50%)
Skin and subcutaneous tissue disorders
Erythema	55/85 (64.7%)		56/88 (63.6%)		59/99 (59.6%)		47/131 (35.9%)		36/130 (27.7%)		40/124 (32.3%)

Limitations/Caveats

[Not Specified]

More Information

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.