Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01392378
• Collaborator: (none)
• Enrollment: 908
• Locations: 14
• Arms: 5
• Duration (Months): 17.1
• Patients Per Site: 64.9
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Vaccines	Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa; Drug: Paracetamol; Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa; Drug: Ibuprofen; Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa; Drug: Paracetamol; Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa; Drug: Ibuprofen; Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 908 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.	Biological: 13-valent pneumococcal conjugate vaccine; 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Biological: INFANRIX hexa; INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Drug: Paracetamol; Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Experimental: Group 2 Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.	Biological: 13-valent pneumococcal conjugate vaccine; 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Biological: INFANRIX hexa; INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Drug: Ibuprofen; Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Experimental: Group 3 Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.	Biological: 13-valent pneumococcal conjugate vaccine; 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Biological: INFANRIX hexa; INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Drug: Paracetamol; Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Experimental: Group 4 Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.	Biological: 13-valent pneumococcal conjugate vaccine; 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Biological: INFANRIX hexa; INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Drug: Ibuprofen; Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Experimental: Group 5 Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.	Biological: 13-valent pneumococcal conjugate vaccine; 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.; Biological: INFANRIX hexa; INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series [1 month after the infant series]

   Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.

Secondary Outcome Measures

1. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series [1 month after the infant series]

   Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

2. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

   Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.

3. Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series [1 month after the infant series]

   Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.

4. Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series [1 month after the infant series]

   Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).

5. Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series [1 month after the infant series]

   Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.

6. Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series [1 month after the infant series]

   Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.

7. Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series [1 month after the infant series]

   Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.

8. Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series [1 month after the infant series]

   Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.

9. Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series [1 month after the infant series]

   Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.

10. Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

    Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.

11. Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose [1 month after the toddler dose]

    Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.

12. Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose [1 month after the toddler dose]

    Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.

13. Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

    Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.

14. Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose [1 month after the toddler dose]

    Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.

15. Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series [1 month after the infant series]

    Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.

16. Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose [1 month after the toddler dose]

    Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.

17. Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 [Within 4 days after infant series Dose 1]

    Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.

18. Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 [Within 4 days after infant series Dose 2]

    Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.

19. Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 [Within 4 days after infant series Dose 3]

    Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.

20. Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose [Within 4 days after toddler dose]

    Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.

21. Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series [Baseline up to 1 Month (28 to 42 days) after infant series]

    An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).

22. Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series [1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose]

    An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).

23. Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose [Toddler dose up to 1 Month (28 to 42 days) after toddler dose]

    An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Days to 98 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 2 months (56 to 98 days) at time of enrollment.

• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.

• A previous anaphylactic reaction to any vaccine or vaccine-related component.

• Allergy or contraindication to paracetamol or ibuprofen administration.

• Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gabinet Lekarski	Debica		Poland	39-200
2	Hanna Czajka Indywidualna Praktyka Lekarska	Krakow		Poland	31-302
3	NZOZ "Praktimed" sp. z o.o.	Krakow		Poland	31-422
4	NZOZ Salmed	Leczna		Poland	21-010
5	Specjalistyczna Praktyka Lekarska Gravita	Lodz		Poland	91-347
6	SP ZOZ Lubartow	Lubartow		Poland	21-100
7	NZOZ Praktyka Lekarza Rodzinnego Eskulap	Lublin		Poland	20-044
8	NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak	Oborniki Slaskie		Poland	55-120
9	Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy	Poznan		Poland	61-734
10	NZLA Michalkowice Jarosz i Partnerzy	Siemianowice Slaskie		Poland	41-103
11	NZOZ Nasz Lekarz	Torun		Poland	87-100
12	Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny	Trzebnica		Poland	55-100
13	DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy	Warszawa		Poland	02-127
14	Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu	Wroclaw		Poland	50-345

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01392378
• Other Study ID Numbers: B1851047; 6096A1-4027
• First Posted: Jul 12, 2011
• Last Update Posted: Feb 26, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Pfizer: Prevenar 13; 13vPnC; Antipyretic medication; Healthy subjects
• Additional relevant MeSH terms: Acetaminophen; Ibuprofen; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Period Title: Infant Series
STARTED	173	176	172	177	210
Vaccinated Dose 1	173	176	172	177	210
Vaccinated Dose 2	171	174	172	177	210
Vaccinated Dose 3	170	174	172	176	210
COMPLETED	169	174	172	175	210
NOT COMPLETED	4	2	0	2	0
Period Title: Infant Series
STARTED	169	174	172	175	210
COMPLETED	169	173	170	175	209
NOT COMPLETED	0	1	2	0	1
Period Title: Infant Series
STARTED	169	173	170	175	209
COMPLETED	169	172	170	173	208
NOT COMPLETED	0	1	0	2	1

Baseline Characteristics

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa	Total
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.	Total of all reporting groups
Overall Participants	173	176	172	177	210	908
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	65.1 (9.5)	66.5 (10.1)	65.6 (9.7)	66.4 (10.3)	65.6 (9.4)	65.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	87 50.3%	89 50.6%	75 43.6%	79 44.6%	98 46.7%	428 47.1%
Male	86 49.7%	87 49.4%	97 56.4%	98 55.4%	112 53.3%	480 52.9%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Description	Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	138	155	148	147	210
4 (n = 137, 155, 148, 146, 210)	1.64	1.99	1.48	2.07	2.02
6B (n = 136, 155, 148, 146, 210)	0.68	0.91	0.56	0.90	0.81
9V (n = 138, 155, 148, 147, 210)	1.13	1.45	1.17	1.40	1.31
14 (n = 138, 155, 148, 147, 210)	4.45	4.73	4.75	5.26	5.38
18C (n = 138, 155, 148, 147, 210)	1.47	1.73	1.25	1.75	1.54
19F (n = 138, 155, 148, 147, 210)	1.78	2.30	1.59	2.04	1.99
23F (n= 137, 155, 148, 146, 210)	0.85	1.19	0.73	1.07	1.04
1 (n = 138, 155, 148, 147, 210)	1.12	1.50	1.02	1.29	1.25
3 (n = 138, 155, 148, 147, 210)	0.71	0.83	0.57	0.84	0.88
5 (n = 137, 155, 148, 146, 210)	0.79	0.98	0.63	0.90	0.81
6A (n = 138, 155, 148, 146, 210)	0.97	1.25	0.85	1.22	1.10
7F (n = 138, 155, 148, 146, 210)	1.94	2.22	1.83	2.28	2.15
19A (n = 137, 155, 148, 146, 210)	2.70	3.39	2.53	3.14	3.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0856
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8546
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4548
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0093
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; 0.53 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1749
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1351
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2158
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3279
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2472
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6193
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0191
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0135
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.68 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1749
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0038
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2053
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0241
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0732
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6090
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95%; 0.56 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7828
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2053
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0093
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0135
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6652
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0275
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.75 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2412
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3121
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0387
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Description	Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	138	155	148	147	210
4 (n = 137, 155, 148, 146, 210)	96.4 55.7%	97.4 55.3%	96.6 56.2%	97.3 55%	98.1 46.7%
6B (n = 136, 155, 148, 146, 210)	72.8 42.1%	80.0 45.5%	61.5 35.8%	79.5 44.9%	77.6 37%
9V (n = 138, 155, 148, 147, 210)	94.2 54.5%	99.4 56.5%	95.9 55.8%	95.9 54.2%	96.2 45.8%
14 (n = 138, 155, 148, 147, 210)	100.0 57.8%	98.7 56.1%	99.3 57.7%	98.6 55.7%	99.5 47.4%
18C (n = 138, 155, 148, 147, 210)	96.4 55.7%	97.4 55.3%	95.3 55.4%	95.9 54.2%	96.7 46%
19F (n = 138, 155, 148, 147, 210)	97.1 56.1%	99.4 56.5%	95.3 55.4%	96.6 54.6%	97.6 46.5%
23F (n = 137, 155, 148, 146, 210)	86.1 49.8%	90.3 51.3%	74.3 43.2%	88.4 49.9%	88.1 42%
1 (n = 138, 155, 148, 147, 210)	94.2 54.5%	97.4 55.3%	90.5 52.6%	94.6 53.4%	94.3 44.9%
3 (n = 138, 155, 148, 147, 210)	83.3 48.2%	89.7 51%	81.1 47.2%	88.4 49.9%	91.0 43.3%
5 (n = 137, 155, 148, 146, 210)	84.7 49%	91.0 51.7%	76.4 44.4%	89.7 50.7%	84.3 40.1%
6A (n = 138, 155, 148, 146, 210)	86.2 49.8%	92.3 52.4%	83.1 48.3%	91.8 51.9%	91.9 43.8%
7F (n = 138, 155, 148, 146, 210)	100.0 57.8%	99.4 56.5%	97.3 56.6%	100.0 56.5%	99.5 47.4%
19A (n = 137, 155, 148, 146, 210)	98.5 56.9%	99.4 56.5%	98.0 57%	99.3 56.1%	100.0 47.6%

3. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Description	Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	130	144	143	139	206
4 (n = 130, 144, 143, 139, 206)	3.07	3.43	2.97	3.43	3.10
6B (n = 130, 144, 143, 139, 206)	6.70	8.01	6.38	7.30	7.08
9V (n = 130, 144, 143, 139, 206)	2.15	2.23	2.17	2.12	2.16
14 (n = 130, 144, 143, 139, 206)	8.10	8.40	7.95	9.12	9.10
18C (n = 130, 144, 143, 139, 206)	1.35	1.68	1.36	1.63	1.59
19F (n = 130, 144, 143, 139, 206)	8.41	8.99	7.53	8.02	7.95
23F (n = 130, 144, 142, 139, 206)	2.34	2.96	2.37	2.86	2.75
1 (n = 130, 144, 143, 139, 206)	2.80	3.22	2.66	3.12	3.04
3 (n = 129, 144, 143, 138, 203)	0.46	0.54	0.46	0.49	0.54
5 (n = 130, 144, 143, 139, 206)	2.33	2.75	2.40	2.62	2.84
6A (n = 130, 144, 143, 139, 206)	5.12	5.73	5.27	5.36	5.52
7F (n = 130, 144, 142, 139, 206)	3.79	3.89	3.56	3.97	3.98
19A (n = 129, 144, 142, 139, 206)	7.11	7.99	7.31	7.35	7.71

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9350
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6922
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6915
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4389
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9350
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9430
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5167
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9872
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2582
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6915
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6922
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9872
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3609
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6304
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2582
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9279
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1424
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.71 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.73 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6304
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6922
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6572
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2514
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9872
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6304
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7918
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6922
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
Description	Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	46	48	44	44	76
4 (n = 37, 46, 42, 41, 61)	100.0 57.8%	100.0 56.8%	100.0 58.1%	100.0 56.5%	100.0 47.6%
6B (n = 36, 45, 43, 40, 62)	94.4 54.6%	88.9 50.5%	88.4 51.4%	92.5 52.3%	96.8 46.1%
9V (n = 37, 48, 42, 41, 65)	62.2 36%	66.7 37.9%	59.5 34.6%	80.5 45.5%	75.4 35.9%
14 (n = 38, 48, 41, 41, 64)	89.5 51.7%	97.9 55.6%	100.0 58.1%	97.6 55.1%	96.9 46.1%
18C (n = 37, 47, 41, 41, 62)	100.0 57.8%	95.7 54.4%	100.0 58.1%	97.6 55.1%	100.0 47.6%
19F (n = 37, 46, 41, 42, 63)	97.3 56.2%	87.0 49.4%	90.2 52.4%	92.9 52.5%	95.2 45.3%
23F (n = 38, 45, 42, 42, 63)	92.1 53.2%	97.8 55.6%	92.9 54%	90.5 51.1%	93.7 44.6%
1 (n = 42, 42, 43, 44, 74)	47.6 27.5%	42.9 24.4%	30.2 17.6%	29.5 16.7%	45.9 21.9%
3 (n = 41, 41, 39, 39, 69)	97.6 56.4%	97.6 55.5%	97.4 56.6%	94.9 53.6%	100.0 47.6%
5 (n = 42, 43, 44, 42, 73)	92.9 53.7%	90.7 51.5%	86.4 50.2%	92.9 52.5%	86.3 41.1%
6A (n = 46, 42, 39, 39, 76)	93.5 54%	100.0 56.8%	100.0 58.1%	100.0 56.5%	98.7 47%
7F (n = 46, 42, 40, 39, 76)	100.0 57.8%	100.0 56.8%	100.0 58.1%	97.4 55%	100.0 47.6%
19A (n = 42, 44, 41, 42, 74)	92.9 53.7%	100.0 56.8%	90.2 52.4%	88.1 49.8%	97.3 46.3%

5. Secondary Outcome

Title	Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
Description	Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	46	48	44	44	76
4 (n = 37, 46, 42, 41, 61)	1269	1135	1240	1361	1086
6B (n = 36, 45, 43, 40, 62)	794	655	470	663	748
9V (n = 37, 48, 42, 41, 65)	120	166	93	285	241
14 (n = 38, 48, 41, 41, 64)	435	622	650	991	951
18C (n = 37, 47, 41, 41, 62)	1094	853	877	1031	1092
19F (n = 37, 46, 41, 42, 63)	346	221	165	294	279
23F (n = 38, 45, 42, 42, 63)	342	441	332	321	366
1 (n = 42, 42, 43, 44, 74)	12	11	8	8	12
3 (n = 41, 41, 39, 39, 69)	72	76	56	62	87
5 (n = 42, 43, 44, 42, 73)	86	96	54	99	76
6A (n = 46, 42, 39, 39, 76)	1060	1681	1228	1281	1462
7F (n = 46, 42, 40, 39, 76)	1766	1907	1747	1584	2125
19A (n = 42, 44, 41, 42, 74)	185	257	163	159	240

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7148
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7907
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4765
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5037
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.52 to 2.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7907
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.45 to 1.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2900
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.32 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.44 to 1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5823
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.18 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.27 to 1.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2407
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.14 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.43 to 3.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0961
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.38 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2900
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.39 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9925
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.52 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3929
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.53 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7433
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.70 to 2.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.46 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2407
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.34 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.51 to 1.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.68 to 2.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7380
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.49 to 1.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9414
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7907
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.58 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2407
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.43 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2670
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.42 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5823
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0422
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2670
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.53 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8454
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.81 to 2.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2824
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.45 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5155
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.83 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5823
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4644
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.56 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8826
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5823
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7636
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3299
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2670
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5823
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.48 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7907
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2742
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.43 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2670
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.42 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
Description	Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	136	146	144	139	198
Geometric Mean (95% Confidence Interval) [mcg/mL]	0.54	0.59	0.49	0.51	0.58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.845
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.461
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.545
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Description	Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	132	143	141	131	193
Pertussis PT	40.86	43.51	40.27	39.26	44.85
Pertussis FHA	46.29	40.65	41.32	35.55	48.42
Pertussis PRN	72.90	71.26	65.82	68.53	84.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.712
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.357
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.190
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.136
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.73 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.104
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.74 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.712
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.206
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.085
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Description	Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	132	143	141	131	193
Tetanus	0.73	0.70	0.69	0.60	0.82
Diphtheria	0.62	0.68	0.61	0.65	0.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.712
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.206
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.104
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.534
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.961
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
Description	Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	105	116	120	112	156
Geometric Mean (95% Confidence Interval) [mIU/mL]	756.42	770.93	689.34	599.12	733.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.408
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Description	Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	89	105	93	84	135
Poliomyelitis Type 1	68.11	66.59	67.43	70.66	72.02
Poliomyelitis Type 2	79.60	73.52	62.12	55.17	67.37
Poliomyelitis Type 3	246.22	184.03	257.92	218.85	231.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.961
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.808
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.408
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.58 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.813
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.343
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.925
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
Description	Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	126	135	141	138	202
Geometric Mean (95% Confidence Interval) [mcg/mL]	9.65	9.35	8.25	7.84	8.96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.914
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Description	Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	123	137	141	136	199
Pertussis PT	77.43	76.93	73.72	73.38	74.01
Pertussis FHA	115.55	117.87	123.56	108.11	117.01
Pertussis PRN	158.28	156.98	160.96	158.71	172.80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.961
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.909
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.914
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.914
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Description	Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	123	137	141	136	199
Tetanus	2.54	2.50	2.60	2.29	2.66
Diphtheria	1.64	1.94	1.69	1.87	1.90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.279
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.75 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.149
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.76 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.394
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.79 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
Description	Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	119	131	133	133	191
Geometric Mean (95% Confidence Interval) [mIU/mL]	4868.61	4148.04	4250.41	4263.28	3866.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.869
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Description	Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	123	133	141	136	201
Poliomyelitis Type 1	399.56	426.63	443.97	415.45	406.37
Poliomyelitis Type 2	613.18	586.30	587.56	605.78	621.07
Poliomyelitis Type 3	1205.80	1045.57	1210.29	1187.11	1237.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.868
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily, 13vPnC + INFANRIX Hexa
	Comments	Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.916
	Comments	P-values were adjusted using false discovery rate procedure.
	Method	General Linear Model
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Description	Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	136	146	144	139	198
Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198)	87.5 50.6%	84.2 47.8%	86.1 50.1%	85.6 48.4%	87.9 41.9%
Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198)	33.8 19.5%	37.0 21%	27.1 15.8%	28.1 15.9%	33.8 16.1%
Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193)	93.2 53.9%	97.2 55.2%	91.5 53.2%	90.8 51.3%	95.3 45.4%
Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193)	96.2 55.6%	92.3 52.4%	93.6 54.4%	88.5 50%	95.3 45.4%
Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193)	90.9 52.5%	87.4 49.7%	88.7 51.6%	89.3 50.5%	95.3 45.4%
Tetanus >=0.1 IU/mL (n = 132,143,141,131,193)	100.0 57.8%	100.0 56.8%	100.0 58.1%	98.5 55.6%	99.5 47.4%
Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193)	100.0 57.8%	98.6 56%	99.3 57.7%	97.7 55.2%	99.5 47.4%
HBV >= 10mIU/mL (n = 105,116,120,112,156)	100.0 57.8%	99.1 56.3%	99.2 57.7%	99.1 56%	98.7 47%
PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135)	97.8 56.5%	98.1 55.7%	97.8 56.9%	100.0 56.5%	99.3 47.3%
PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135)	95.5 55.2%	98.1 55.7%	95.7 55.6%	96.4 54.5%	95.6 45.5%
PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135)	100.0 57.8%	100.0 56.8%	98.9 57.5%	98.8 55.8%	99.3 47.3%

17. Secondary Outcome

Title	Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Description	Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	126	137	141	138	202
Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202)	100.0 57.8%	99.3 56.4%	100.0 58.1%	100.0 56.5%	100.0 47.6%
Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202)	95.2 55%	96.3 54.7%	95.7 55.6%	95.7 54.1%	95.0 45.2%
Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199)	97.6 56.4%	99.3 56.4%	98.6 57.3%	100.0 56.5%	95.5 45.5%
Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199)	91.1 52.7%	94.9 53.9%	93.6 54.4%	92.6 52.3%	95.5 45.5%
Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199)	91.9 53.1%	94.9 53.9%	94.3 54.8%	94.1 53.2%	95.5 45.5%
Tetanus >=0.1 IU/mL (n = 123,137,141,136,199)	100.0 57.8%	100.0 56.8%	100.0 58.1%	100.0 56.5%	100.0 47.6%
Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199)	100.0 57.8%	100.0 56.8%	100.0 58.1%	100.0 56.5%	100.0 47.6%
HBV >= 10 mIU/mL (n = 119,131,133,133,191)	100.0 57.8%	98.5 56%	100.0 58.1%	100.0 56.5%	99.5 47.4%
Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201)	99.2 57.3%	100.0 56.8%	100.0 58.1%	100.0 56.5%	99.5 47.4%
Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201)	100.0 57.8%	100.0 56.8%	100.0 58.1%	100.0 56.5%	100.0 47.6%
Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201)	100.0 57.8%	100.0 56.8%	100.0 58.1%	100.0 56.5%	100.0 47.6%

18. Secondary Outcome

Title	Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Description	Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.
Time Frame	Within 4 days after infant series Dose 1

Outcome Measure Data

Analysis Population Description

Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. 'N'(number of participants analyzed)=participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	149	157	147	155	187
Fever >=38, <=39 degree C (n= 149,157,147,155,187)	32.9 19%	45.2 25.7%	18.4 10.7%	34.2 19.3%	41.7 19.9%
Fever >39, <=40 degree C (n = 138,145,137,146,170)	1.4 0.8%	1.4 0.8%	0.7 0.4%	0.7 0.4%	1.2 0.6%
Fever >40 degree C (n = 138,145,137,146,170)	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%

19. Secondary Outcome

Title	Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Description	Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Time Frame	Within 4 days after infant series Dose 2

Outcome Measure Data

Analysis Population Description

Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	141	152	140	159	181
Fever >=38, <=39 degree C (n= 141,152,140,159,181)	26.2 15.1%	42.8 24.3%	21.4 12.4%	44.0 24.9%	39.8 19%
Fever >39, <=40 degree C (n = 133,140,134,145,164)	1.5 0.9%	0.7 0.4%	1.5 0.9%	1.4 0.8%	3.7 1.8%
Fever >40 degree C (n = 131,140,133,144,164)	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%

20. Secondary Outcome

Title	Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Description	Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
Time Frame	Within 4 days after infant series Dose 3

Outcome Measure Data

Analysis Population Description

Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	136	146	135	141	175
Fever >=38, <=39 degree C (n= 136,146,135,141,175)	22.1 12.8%	30.8 17.5%	17.0 9.9%	33.3 18.8%	29.7 14.1%
Fever >39, <=40 degree C (n = 129,137,125,136,167)	1.6 0.9%	2.9 1.6%	0.8 0.5%	1.5 0.8%	1.8 0.9%
Fever >40 degree C (n = 128,136,126,135,166)	0.0 0%	0.0 0%	0.8 0.5%	0.0 0%	0.0 0%

21. Secondary Outcome

Title	Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Description	Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Time Frame	Within 4 days after toddler dose

Outcome Measure Data

Analysis Population Description

Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n' =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	133	140	134	144	162
Fever >=38, <=39 degree C (n= 133,140,134,144,162)	31.6 18.3%	37.1 21.1%	37.3 21.7%	50.0 28.2%	30.2 14.4%
Fever >39, <=40 degree C (n = 128,127,118,123,150)	5.5 3.2%	7.1 4%	4.2 2.4%	5.7 3.2%	2.0 1%
Fever >40 degree C (n = 123,125,117,122,150)	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%

22. Secondary Outcome

Title	Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
Description	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Time Frame	Baseline up to 1 Month (28 to 42 days) after infant series

Outcome Measure Data

Analysis Population Description

Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	173	176	172	177	210
Non-SAEs	57 32.9%	71 40.3%	67 39%	72 40.7%	80 38.1%
SAEs	7 4%	3 1.7%	11 6.4%	8 4.5%	10 4.8%

23. Secondary Outcome

Title	Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
Description	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).
Time Frame	1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose

Outcome Measure Data

Analysis Population Description

Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	170	174	172	176	210
Non-SAEs	3 1.7%	6 3.4%	3 1.7%	4 2.3%	8 3.8%
SAEs	6 3.5%	14 8%	10 5.8%	11 6.2%	9 4.3%

24. Secondary Outcome

Title	Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
Description	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Time Frame	Toddler dose up to 1 Month (28 to 42 days) after toddler dose

Outcome Measure Data

Analysis Population Description

Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.

Arm/Group Title	13vPnC + INFANRIX Hexa + Paracetamol Twice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily	13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily	13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily	13vPnC + INFANRIX Hexa
Arm/Group Description	Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.	Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Measure Participants	169	173	170	175	209
Non-SAEs	47 27.2%	57 32.4%	52 30.2%	76 42.9%	50 23.8%
SAEs	3 1.7%	2 1.1%	1 0.6%	1 0.6%	1 0.5%

Adverse Events

Time Frame	AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Adverse Event Reporting Description	Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
Arm/Group Title	13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series		13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series		13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series		13vPnC + INFANRIX Hexa - Infant Series		13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser		13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser		13vPnC + INFANRIX Hexa - After Infant Series		13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose		13vPnC + INFANRIX Hexa - Toddler Dose
Arm/Group Description	Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.		Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
All Cause Mortality
	13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series		13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series		13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series		13vPnC + INFANRIX Hexa - Infant Series		13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser		13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser		13vPnC + INFANRIX Hexa - After Infant Series		13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose		13vPnC + INFANRIX Hexa - Toddler Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series		13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series		13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series		13vPnC + INFANRIX Hexa - Infant Series		13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser		13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser		13vPnC + INFANRIX Hexa - After Infant Series		13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose		13vPnC + INFANRIX Hexa - Toddler Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/173 (4%)		3/176 (1.7%)		11/172 (6.4%)		8/177 (4.5%)		10/210 (4.8%)		6/170 (3.5%)		14/174 (8%)		10/172 (5.8%)		11/176 (6.3%)		9/210 (4.3%)		3/169 (1.8%)		2/173 (1.2%)		1/170 (0.6%)		1/175 (0.6%)		1/209 (0.5%)
Congenital, familial and genetic disorders
Ventricular septal defect	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastrointestinal disorders
Constipation	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Diarrhoea	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		1/174 (0.6%)		1/172 (0.6%)		2/176 (1.1%)		3/210 (1.4%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Diarrhoea haemorrhagic	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastrooesophageal reflux disease	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Stomatitis	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dyspepsia	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Rectal haemorrhage	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Infections and infestations
Bronchiolitis	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		1/176 (0.6%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Bronchitis	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		2/177 (1.1%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		2/176 (1.1%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Bronchopneumonia	2/173 (1.2%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Exanthema subitum	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		1/170 (0.6%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastroenteritis	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		1/210 (0.5%)		2/170 (1.2%)		4/174 (2.3%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		0/175 (0%)		0/209 (0%)
Laryngitis	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Lower respiratory tract infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Nasopharyngitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Otitis media	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Otitis media acute	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pertussis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pneumonia	2/173 (1.2%)		0/176 (0%)		3/172 (1.7%)		2/177 (1.1%)		2/210 (1%)		1/170 (0.6%)		1/174 (0.6%)		2/172 (1.2%)		2/176 (1.1%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Upper respiratory tract infection	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		2/174 (1.1%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Urinary tract infection	1/173 (0.6%)		2/176 (1.1%)		1/172 (0.6%)		2/177 (1.1%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		2/176 (1.1%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Bacterial infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Ear infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastroenteritis Escherichia coli	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastroenteritis rotavirus	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		3/174 (1.7%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pyelonephritis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Respiratory tract infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		1/170 (0.6%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Respiratory tract infection viral	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pharyngitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		1/175 (0.6%)		0/209 (0%)
Viral infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Injury, poisoning and procedural complications
Head injury	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		2/169 (1.2%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Exposure to toxic agent	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Thermal burn	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Nervous system disorders
Movement disorder	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		1/170 (0.6%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Psychiatric disorders
Breath holding	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		1/170 (0.6%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series		13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series		13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series		13vPnC + INFANRIX Hexa - Infant Series		13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser		13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser		13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser		13vPnC + INFANRIX Hexa - After Infant Series		13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose		13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose		13vPnC + INFANRIX Hexa - Toddler Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/173 (32.9%)		71/176 (40.3%)		67/172 (39%)		72/177 (40.7%)		80/210 (38.1%)		3/170 (1.8%)		6/174 (3.4%)		3/172 (1.7%)		4/176 (2.3%)		8/210 (3.8%)		47/169 (27.8%)		57/173 (32.9%)		52/170 (30.6%)		76/175 (43.4%)		50/209 (23.9%)
Blood and lymphatic system disorders
Anaemia	0/173 (0%)		1/176 (0.6%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Iron deficiency anaemia	2/173 (1.2%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Congenital, familial and genetic disorders
Atrial septal defect	1/173 (0.6%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Hydrocele	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Patent ductus arteriosus	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Keratosis follicular	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Endocrine disorders
Hypothyroidism	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Eye disorders
Conjunctivitis	1/173 (0.6%)		3/176 (1.7%)		7/172 (4.1%)		5/177 (2.8%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Dacryostenosis acquired	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastrointestinal disorders
Abdominal pain	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Aphthous stomatitis	0/173 (0%)		0/176 (0%)		3/172 (1.7%)		1/177 (0.6%)		2/210 (1%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Constipation	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Diarrhoea	1/173 (0.6%)		2/176 (1.1%)		5/172 (2.9%)		4/177 (2.3%)		2/210 (1%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		3/169 (1.8%)		1/173 (0.6%)		1/170 (0.6%)		5/175 (2.9%)		2/209 (1%)
Dyschezia	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dyspepsia	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Flatulence	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastrooesophageal reflux disease	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gingival pain	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Haematochezia	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Intestinal haemorrhage	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Teething	0/173 (0%)		0/176 (0%)		0/172 (0%)		2/177 (1.1%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Vomiting	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Inguinal hernia	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		1/170 (0.6%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Stomatitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		3/170 (1.8%)		0/175 (0%)		1/209 (0.5%)
Toothache	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		0/175 (0%)		0/209 (0%)
General disorders
Adverse drug reaction	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Crying	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Irritability	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pyrexia	2/173 (1.2%)		6/176 (3.4%)		5/172 (2.9%)		2/177 (1.1%)		2/210 (1%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		3/173 (1.7%)		1/170 (0.6%)		3/175 (1.7%)		2/209 (1%)
Vaccination site nodule	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Vaccination site swelling	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Fever >=38, <=39 degree C	49/149 (32.9%)		71/157 (45.2%)		27/147 (18.4%)		53/155 (34.2%)		78/187 (41.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		42/133 (31.6%)		52/140 (37.1%)		50/134 (37.3%)		72/144 (50%)		49/162 (30.2%)
Fever >39, <=40 degree C	2/138 (1.4%)		2/145 (1.4%)		1/137 (0.7%)		1/146 (0.7%)		2/170 (1.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		7/128 (5.5%)		9/127 (7.1%)		5/118 (4.2%)		7/123 (5.7%)		3/150 (2%)
Fever >40 degree C	0/138 (0%)		0/145 (0%)		0/137 (0%)		0/146 (0%)		0/170 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/123 (0%)		0/125 (0%)		0/117 (0%)		0/122 (0%)		0/150 (0%)
Fever >=38, <=39 degree C	37/141 (26.2%)		65/152 (42.8%)		30/140 (21.4%)		70/159 (44%)		72/181 (39.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39, <=40 degree C	2/133 (1.5%)		1/140 (0.7%)		2/134 (1.5%)		2/145 (1.4%)		6/164 (3.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40 degree C	0/131 (0%)		0/140 (0%)		0/133 (0%)		0/144 (0%)		0/164 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >=38, <=39 degree C	30/136 (22.1%)		45/146 (30.8%)		23/135 (17%)		47/141 (33.3%)		52/175 (29.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39, <=40 degree C	2/129 (1.6%)		4/137 (2.9%)		1/125 (0.8%)		2/136 (1.5%)		3/167 (1.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40 degree C	0/128 (0%)		0/136 (0%)		1/126 (0.8%)		0/135 (0%)		0/166 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Immune system disorders
Milk allergy	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Food allergy	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Infections and infestations
Anal abscess	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Bronchitis	9/173 (5.2%)		8/176 (4.5%)		11/172 (6.4%)		9/177 (5.1%)		5/210 (2.4%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		2/169 (1.2%)		0/173 (0%)		3/170 (1.8%)		5/175 (2.9%)		2/209 (1%)
Bronchopneumonia	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Candidiasis	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Conjunctivitis infective	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Cystitis	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Ear infection	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Exanthema subitum	0/173 (0%)		4/176 (2.3%)		1/172 (0.6%)		0/177 (0%)		2/210 (1%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		2/169 (1.2%)		1/173 (0.6%)		4/170 (2.4%)		0/175 (0%)		1/209 (0.5%)
Gastroenteritis	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		1/175 (0.6%)		1/209 (0.5%)
Impetigo	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Laryngitis	1/173 (0.6%)		2/176 (1.1%)		3/172 (1.7%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		2/209 (1%)
Lower respiratory tract infection	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Nasopharyngitis	11/173 (6.4%)		6/176 (3.4%)		10/172 (5.8%)		8/177 (4.5%)		18/210 (8.6%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		1/169 (0.6%)		2/173 (1.2%)		4/170 (2.4%)		2/175 (1.1%)		1/209 (0.5%)
Oral candidiasis	0/173 (0%)		0/176 (0%)		2/172 (1.2%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Otitis media	1/173 (0.6%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		2/210 (1%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		1/175 (0.6%)		0/209 (0%)
Otitis media acute	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Pharyngitis	4/173 (2.3%)		6/176 (3.4%)		5/172 (2.9%)		4/177 (2.3%)		3/210 (1.4%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		2/173 (1.2%)		5/170 (2.9%)		0/175 (0%)		0/209 (0%)
Pneumonia	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		2/210 (1%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Respiratory tract infection	4/173 (2.3%)		7/176 (4%)		4/172 (2.3%)		5/177 (2.8%)		3/210 (1.4%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		6/175 (3.4%)		2/209 (1%)
Rhinitis	3/173 (1.7%)		7/176 (4%)		11/172 (6.4%)		10/177 (5.6%)		9/210 (4.3%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		2/169 (1.2%)		4/173 (2.3%)		5/170 (2.9%)		3/175 (1.7%)		5/209 (2.4%)
Upper respiratory tract infection	15/173 (8.7%)		12/176 (6.8%)		14/172 (8.1%)		17/177 (9.6%)		12/210 (5.7%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		7/169 (4.1%)		7/173 (4%)		3/170 (1.8%)		4/175 (2.3%)		7/209 (3.3%)
Urinary tract infection	0/173 (0%)		1/176 (0.6%)		3/172 (1.7%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Varicella	1/173 (0.6%)		2/176 (1.1%)		0/172 (0%)		3/177 (1.7%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		1/175 (0.6%)		0/209 (0%)
Viral upper respiratory tract infection	2/173 (1.2%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		1/175 (0.6%)		0/209 (0%)
Coxsackie viral infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Gastroenteritis viral	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		0/175 (0%)		0/209 (0%)
Tonsillitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		0/175 (0%)		1/209 (0.5%)
Viral infection	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		1/170 (0.6%)		0/175 (0%)		0/209 (0%)
Injury, poisoning and procedural complications
Head injury	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Mouth injury	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Contusion	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Thermal burn	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Investigations
Cardiac murmur	0/173 (0%)		2/176 (1.1%)		3/172 (1.7%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		1/169 (0.6%)		3/173 (1.7%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Weight increased	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		1/173 (0.6%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Metabolism and nutrition disorders
Calcium metabolism disorder	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Weight gain poor	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Musculoskeletal and connective tissue disorders
Muscle tightness	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Foot deformity	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Nervous system disorders
Hypertonia	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Hypotonia	1/173 (0.6%)		0/176 (0%)		1/172 (0.6%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Neuromyopathy	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Psychiatric disorders
Apathy	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Psychomotor retardation	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Renal and urinary disorders
Hypercalciuria	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Vesicoureteric reflux	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		1/172 (0.6%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Reproductive system and breast disorders
Genital labial adhesions	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Breast enlargement	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Rhinitis allergic	0/173 (0%)		0/176 (0%)		1/172 (0.6%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Asthma	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Skin and subcutaneous tissue disorders
Cafe au lait spots	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		1/170 (0.6%)		0/174 (0%)		0/172 (0%)		1/176 (0.6%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dermatitis allergic	3/173 (1.7%)		1/176 (0.6%)		1/172 (0.6%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		1/174 (0.6%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		2/170 (1.2%)		0/175 (0%)		0/209 (0%)
Dermatitis atopic	2/173 (1.2%)		2/176 (1.1%)		1/172 (0.6%)		1/177 (0.6%)		4/210 (1.9%)		1/170 (0.6%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		2/169 (1.2%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dermatitis contact	0/173 (0%)		0/176 (0%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dermatitis diaper	0/173 (0%)		1/176 (0.6%)		1/172 (0.6%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		1/169 (0.6%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Eczema	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Rash	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		1/177 (0.6%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		1/170 (0.6%)		1/175 (0.6%)		0/209 (0%)
Seborrhoeic dermatitis	1/173 (0.6%)		2/176 (1.1%)		1/172 (0.6%)		1/177 (0.6%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Skin depigmentation	1/173 (0.6%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Urticaria	0/173 (0%)		1/176 (0.6%)		0/172 (0%)		0/177 (0%)		1/210 (0.5%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Petechiae	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		1/210 (0.5%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		0/209 (0%)
Dermatitis	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		1/175 (0.6%)		0/209 (0%)
Rash papular	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		2/175 (1.1%)		0/209 (0%)
Rash pruritic	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)
Skin discolouration	0/173 (0%)		0/176 (0%)		0/172 (0%)		0/177 (0%)		0/210 (0%)		0/170 (0%)		0/174 (0%)		0/172 (0%)		0/176 (0%)		0/210 (0%)		0/169 (0%)		0/173 (0%)		0/170 (0%)		0/175 (0%)		1/209 (0.5%)

Limitations/Caveats

[Not Specified]

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.