Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

• ClinicalTrials.gov Identifier: NCT02096263
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: August 1, 2018
• Last Update Posted: November 27, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Tetanus; Acellular Pertussis; Hepatitis B
• Interventions: Biological: Infanrix hexa; Biological: Pediarix; Biological: ActHIB; Biological: Pentacel; Biological: Engerix-B; Biological: Infanrix; Biological: Hiberix; Biological: Prevnar13; Biological: Rotarix
• Enrollment: 585

Participant Flow

Recruitment Details	This study was conducted in 43 centers in the United States of America (USA).
Pre-assignment Details

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Period Title: Overall Study
Started	195	194	196
Completed	161	158	157
Not Completed	34	36	39
Reason Not Completed
Adverse Event	1	0	1
Lost to Follow-up	14	18	15
Other	7	9	6
Sponsor study termination	0	0	1
Protocol Violation	7	2	8
Withdrawal by Subject	5	7	8

Baseline Characteristics

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group	Total
Arm/Group Description		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Total of all reporting groups
Overall Number of Baseline Participants		195	194	196	585
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Weeks
	Number Analyzed	195 participants	194 participants	196 participants	585 participants
		8.5 (1.0)	8.6 (1.1)	8.6 (1.1)	8.6 (1.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	195 participants	194 participants	196 participants	585 participants
	Female	101 51.8%	80 41.2%	95 48.5%	276 47.2%
	Male	94 48.2%	114 58.8%	101 51.5%	309 52.8%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	195 participants	194 participants	196 participants	585 participants
Asian - Japanese Heritage		1 0.5%	0 0.0%	1 0.5%	2 0.3%
African Heritage / African American		16 8.2%	9 4.6%	20 10.2%	45 7.7%
Asian - East Asian Heritage		3 1.5%	2 1.0%	0 0.0%	5 0.9%
White - Caucasian / European Heritage		118 60.5%	128 66.0%	115 58.7%	361 61.7%
Asian - Central/South Asian Heritage		2 1.0%	2 1.0%	1 0.5%	5 0.9%
White - Arabic / North African Heritage		0 0.0%	1 0.5%	0 0.0%	1 0.2%
Unspecified		29 14.9%	27 13.9%	32 16.3%	88 15.0%
American Indian or Alaskan Native		15 7.7%	15 7.7%	17 8.7%	47 8.0%
Native Hawaiian or Other Pacific Islander		2 1.0%	1 0.5%	2 1.0%	5 0.9%
Asian - South East Asian Heritage		9 4.6%	9 4.6%	8 4.1%	26 4.4%

Outcome Measures

1. Primary Outcome

Title	Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Description	Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
Time Frame	At Month 5, one month after the third dose of the primary vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	146	149	149
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
Anti-PT	43.2; (38.1 to 48.9)	48.3; (42.7 to 54.5)	24.2; (21.1 to 27.7)
Anti-FHA	106.3; (95.0 to 119.0)	122.7; (109.9 to 137.0)	59.9; (51.7 to 69.3)
Anti-PRN	57.4; (49.5 to 66.6)	46.9; (39.9 to 55.3)	33.0; (27.8 to 39.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Infanrix Hexa Group, Pediarix Group
	Comments	To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.31
	Estimation Comments	Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Infanrix Hexa Group, Pediarix Group
	Comments	To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.35
	Estimation Comments	Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Infanrix Hexa Group, Pediarix Group
	Comments	To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.99
	Estimation Comments	Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).

2. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Description	A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time Frame	At Month 5, one month after the third dose of the primary vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	146	149	149
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-PT	146 100.0%	148 99.3%	148 99.3%
Anti-FHA	146 100.0%	149 100.0%	149 100.0%
Anti-PRN	146 100.0%	148 99.3%	148 99.3%

3. Secondary Outcome

Title	Number of Seroprotected Subjects Against Tetanus (T).
Description	A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	146	149	149
Measure Type: Count of Participants; Unit of Measure: Participants
	146 100.0%	149 100.0%	148 99.3%

4. Secondary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria (D).
Description	A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	142	144	149
Measure Type: Count of Participants; Unit of Measure: Participants
	142 100.0%	144 100.0%	149 100.0%

5. Secondary Outcome

Title	Antibody Concentrations for Anti-T.
Description	Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	146	149	149
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
	2.458; (2.195 to 2.753)	2.633; (2.338 to 2.966)	2.012; (1.768 to 2.290)

6. Secondary Outcome

Title	Antibody Concentrations for Anti-D.
Description	Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	142	144	149
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
	1.777; (1.551 to 2.036)	1.648; (1.44 to 1.886)	1.249; (1.095 to 1.425)

7. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
Description	A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		137	134	136
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-polio 1	Number Analyzed	137 participants	134 participants	136 participants
		137 100.0%	134 100.0%	135 99.3%
Anti-polio 2	Number Analyzed	133 participants	131 participants	134 participants
		133 100.0%	131 100.0%	134 100.0%
Anti-polio 3	Number Analyzed	129 participants	132 participants	126 participants
		129 100.0%	132 100.0%	124 98.4%

8. Secondary Outcome

Title	Antibody Titres for Anti-polio Types 1, 2 and 3.
Description	Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		137	134	136
Geometric Mean (95% Confidence Interval); Unit of Measure: titres
Anti-polio 1	Number Analyzed	137 participants	134 participants	136 participants
		546.9; (447.7 to 668.0)	604.1; (495.9 to 736.0)	319.5; (256.8 to 397.5)
Anti-polio 2	Number Analyzed	133 participants	131 participants	134 participants
		483.5; (394.2 to 593.0)	567.7; (448.8 to 718.1)	283.0; (229.4 to 349.2)
Anti-polio 3	Number Analyzed	129 participants	132 participants	126 participants
		722.2; (577.4 to 903.4)	927.0; (740.7 to 1160.3)	294.6; (221.6 to 391.7)

9. Secondary Outcome

Title	Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).
Description	A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	154	154	156
Measure Type: Count of Participants; Unit of Measure: Participants
	146 94.8%	151 98.1%	154 98.7%

10. Secondary Outcome

Title	Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
Description	The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	154	154	156
Measure Type: Count of Participants; Unit of Measure: Participants
	85 55.2%	145 94.2%	130 83.3%

11. Secondary Outcome

Title	Antibody Concentrations for Anti-PRP.
Description	Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	154	154	156
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/mL
	1.348; (1.076 to 1.688)	9.258; (7.362 to 11.642)	5.717; (4.363 to 7.492)

12. Secondary Outcome

Title	Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).
Description	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	134	138	136
Measure Type: Count of Participants; Unit of Measure: Participants
	134 100.0%	138 100.0%	133 97.8%

13. Secondary Outcome

Title	Antibody Concentrations for Anti-HBs.
Description	Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time Frame	At Month 5, one month after the third dose of the primary vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	134	138	136
Geometric Mean (95% Confidence Interval); Unit of Measure: mIU/mL
	2258.8; (1910.7 to 2670.4)	1886.0; (1565.6 to 2271.9)	1053.4; (780.2 to 1422.4)

14. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 1

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	185	189	188
Measure Type: Count of Participants; Unit of Measure: Participants
Any Pain, ActHIB/Engerix	NA [1]	123 65.1%	100 53.2%
≥ G 2 Pain, ActHIB/Engerix	NA [1]	66 34.9%	45 23.9%
G 3 Pain, ActHIB/Engerix	NA [1]	22 11.6%	10 5.3%
MA Pain, ActHIB/Engerix	NA [1]	1 0.5%	0 0.0%
Any Pain, Infanrix hexa/Pediarix/Pentacel	94 50.8%	113 59.8%	115 61.2%
≥ G 2 Pain, Infanrix hexa/Pediarix/Pentacel	40 21.6%	65 34.4%	51 27.1%
G 3 Pain, Infanrix hexa/Pediarix/Pentacel	8 4.3%	17 9.0%	12 6.4%
MA Pain, Infanrix hexa/Pediarix/Pentacel	1 0.5%	0 0.0%	0 0.0%
Any Redness, ActHIB/Engerix	NA [1]	63 33.3%	55 29.3%
≥ G 2 Redness, ActHIB/Engerix	NA [1]	19 10.1%	12 6.4%
G 3 Redness, ActHIB/Engerix	NA [1]	8 4.2%	1 0.5%
MA Redness, ActHIB/Engerix	NA [1]	1 0.5%	0 0.0%
Any Redness, Infanrix hexa/Pediarix/Pentacel	47 25.4%	56 29.6%	57 30.3%
≥ G 2 Redness, Infanrix hexa/Pediarix/Pentacel	15 8.1%	15 7.9%	20 10.6%
G 3 Redness, Infanrix hexa/Pediarix/Pentacel	3 1.6%	4 2.1%	3 1.6%
MA Redness, Infanrix hexa/Pediarix/Pentacel	0 0.0%	0 0.0%	0 0.0%
Any Swelling, ActHIB/Engerix	NA [1]	41 21.7%	39 20.7%
≥ G 2 Swelling, ActHIB/Engerix	NA [1]	14 7.4%	14 7.4%
G 3 Swelling, ActHIB/Engerix	NA [1]	6 3.2%	3 1.6%
MA Swelling, ActHIB/Engerix	NA [1]	1 0.5%	0 0.0%
Any Swelling, Infanrix hexa/Pediarix/Pentacel	31 16.8%	35 18.5%	45 23.9%
≥ G 2 Swelling, Infanrix hexa/Pediarix/Pentacel	10 5.4%	14 7.4%	24 12.8%
G 3 Swelling, Infanrix hexa/Pediarix/Pentacel	2 1.1%	3 1.6%	11 5.9%
MA Swelling, Infanrix hexa/Pediarix/Pentacel	0 0.0%	0 0.0%	0 0.0%

[1]

Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.

15. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		182	184	180
Measure Type: Count of Participants; Unit of Measure: Participants
Any Pain, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	104 56.5%	6 46.2%
≥ G 2 Pain, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	47 25.5%	2 15.4%
G 3 Pain, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	9 4.9%	0 0.0%
MA Pain, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	0 0.0%	0 0.0%
Any Pain,Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		84 46.2%	108 58.7%	93 51.7%
≥G2 Pain,Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		25 13.7%	44 23.9%	31 17.2%
G3 Pain,Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		1 0.5%	7 3.8%	6 3.3%
MA Pain, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		0 0.0%	0 0.0%	0 0.0%
Any Redness, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	66 35.9%	5 38.5%
≥ G 2 Redness, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	17 9.2%	1 7.7%
G 3 Redness, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	1 0.5%	0 0.0%
MA Redness, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	0 0.0%	0 0.0%
Any Red, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		59 32.4%	61 33.2%	64 35.6%
≥G2 Red,Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		15 8.2%	12 6.5%	15 8.3%
G 3 Red, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		3 1.6%	3 1.6%	2 1.1%
MA Red, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		0 0.0%	0 0.0%	0 0.0%
Any Swelling, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	40 21.7%	3 23.1%
≥ G 2 Swelling, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	11 6.0%	0 0.0%
G 3 Swelling, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	1 0.5%	0 0.0%
MA Swelling, ActHIB/Engerix	Number Analyzed	182 participants	184 participants	13 participants
		NA [1]	0 0.0%	0 0.0%
Any Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		41 22.5%	40 21.7%	42 23.3%
≥G2 Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		10 5.5%	12 6.5%	7 3.9%
G 3 Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		2 1.1%	2 1.1%	3 1.7%
MA Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	182 participants	184 participants	180 participants
		0 0.0%	0 0.0%	0 0.0%

[1]

Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.

16. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 3

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		172	175	171
Measure Type: Count of Participants; Unit of Measure: Participants
Any Pain, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	93 53.1%	75 44.4%
≥ G 2 Pain, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	41 23.4%	25 14.8%
G 3 Pain, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	7 4.0%	5 3.0%
MA Pain, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	1 0.6%	0 0.0%
Any Pain, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		67 39.0%	90 51.4%	76 44.7%
≥ G2 Pain, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		18 10.5%	39 22.3%	20 11.8%
G3 Pain, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		0 0.0%	7 4.0%	7 4.1%
MA Pain, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		0 0.0%	1 0.6%	0 0.0%
Any Red, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	69 39.4%	51 30.2%
≥ G 2 Red, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	7 4.0%	9 5.3%
G 3 Red, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	1 0.6%	2 1.2%
MA Red, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	0 0.0%	0 0.0%
Any Red, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		63 36.6%	66 37.7%	56 32.9%
≥G2 Red, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		7 4.1%	12 6.9%	11 6.5%
G3 Red, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		1 0.6%	3 1.7%	0 0.0%
MA Red, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		0 0.0%	1 0.6%	0 0.0%
Any Swe, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	42 24.0%	37 21.9%
≥ G 2 Swe, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	7 4.0%	7 4.1%
G 3 Swe, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	1 0.6%	0 0.0%
MA Swe, ActHIB/Engerix	Number Analyzed	172 participants	175 participants	169 participants
		NA [1]	0 0.0%	0 0.0%
Any Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		43 25.0%	44 25.1%	35 20.6%
≥ G2 Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		7 4.1%	10 5.7%	4 2.4%
G3 Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		1 0.6%	3 1.7%	0 0.0%
MA Swe, Infanrix/Pediarix/Pentacel	Number Analyzed	172 participants	175 participants	170 participants
		0 0.0%	1 0.6%	0 0.0%

[1]

Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.

17. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following any dose.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	187	189	188
Measure Type: Count of Participants; Unit of Measure: Participants
Any Pain, ActHIB/Engerix	NA [1]	148 78.3%	127 67.6%
≥ G 2 Pain, ActHIB/Engerix	NA [1]	96 50.8%	62 33.0%
G 3 Pain, ActHIB/Engerix	NA [1]	30 15.9%	14 7.4%
MA Pain, ActHIB/Engerix	NA [1]	2 1.1%	0 0.0%
Any Pain, Infanrix/Pediarix/Pentacel	127 67.9%	151 79.9%	147 78.2%
≥ G2 Pain, Infanrix/Pediarix/Pentacel	58 31.0%	93 49.2%	80 42.6%
G3 Pain, Infanrix/Pediarix/Pentacel	8 4.3%	27 14.3%	22 11.7%
MA Pain, Infanrix/Pediarix/Pentacel	1 0.5%	1 0.5%	0 0.0%
Any Red, ActHIB/Engerix	NA [1]	108 57.1%	77 41.0%
≥ G 2 Red, ActHIB/Engerix	NA [1]	38 20.1%	20 10.6%
G 3 Red, ActHIB/Engerix	NA [1]	10 5.3%	3 1.6%
MA Red, ActHIB/Engerix	NA [1]	1 0.5%	0 0.0%
Any Red, Infanrix/Pediarix/Pentacel	94 50.3%	98 51.9%	87 46.3%
≥ G2 Red, Infanrix/Pediarix/Pentacel	27 14.4%	32 16.9%	37 19.7%
G3 Red, Infanrix/Pediarix/Pentacel	7 3.7%	9 4.8%	5 2.7%
MA Red, Infanrix/Pediarix/Pentacel	0 0.0%	1 0.5%	0 0.0%
Any Swe, ActHIB/Engerix	NA [1]	78 41.3%	64 34.0%
≥ G 2 Swe, ActHIB/Engerix	NA [1]	25 13.2%	18 9.6%
G 3 Swe, ActHIB/Engerix	NA [1]	7 3.7%	3 1.6%
MA Swe, ActHIB/Engerix	NA [1]	1 0.5%	0 0.0%
Any Swe, Infanrix/Pediarix/Pentacel	73 39.0%	70 37.0%	72 38.3%
≥ G2 Swe, Infanrix/Pediarix/Pentacel	20 10.7%	26 13.8%	26 13.8%
G3 Swe, Infanrix/Pediarix/Pentacel	4 2.1%	7 3.7%	12 6.4%
MA Swe, Infanrix/Pediarix/Pentacel	0 0.0%	1 0.5%	0 0.0%

[1]

Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.

18. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 1.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	185	189	188
Measure Type: Count of Participants; Unit of Measure: Participants
Any Drowsiness	114 61.6%	143 75.7%	149 79.3%
≥ G 2 Drowsiness	36 19.5%	56 29.6%	53 28.2%
G 3 Drowsiness	3 1.6%	8 4.2%	12 6.4%
Rel Drowsiness	112 60.5%	136 72.0%	141 75.0%
G3 Rel Drowsiness	3 1.6%	7 3.7%	12 6.4%
MA Drowsiness	1 0.5%	0 0.0%	0 0.0%
Any Irritability / Fussiness	115 62.2%	165 87.3%	153 81.4%
≥ G 2 Irritability / Fussiness	42 22.7%	79 41.8%	68 36.2%
G 3 Irritability / Fussiness	9 4.9%	17 9.0%	15 8.0%
Rel Irritability / Fussiness	113 61.1%	163 86.2%	147 78.2%
G3 Rel Irritability / Fussiness	9 4.9%	17 9.0%	15 8.0%
MA Irritability / Fussiness	1 0.5%	0 0.0%	0 0.0%
Any Loss of appetite	53 28.6%	76 40.2%	80 42.6%
≥ G 2 Loss of appetite	8 4.3%	13 6.9%	26 13.8%
G 3 Loss of appetite	0 0.0%	1 0.5%	4 2.1%
Rel Loss of appetite	48 25.9%	73 38.6%	77 41.0%
G3 Rel Loss of appetite	0 0.0%	1 0.5%	4 2.1%
MA Loss of appetite	0 0.0%	0 0.0%	0 0.0%
Any Fever	22 11.9%	34 18.0%	29 15.4%
≥ G 2 Fever	0 0.0%	0 0.0%	2 1.1%
G 3 Fever	0 0.0%	0 0.0%	0 0.0%
Rel Fever	15 8.1%	31 16.4%	27 14.4%
G3 Rel Fever	0 0.0%	0 0.0%	0 0.0%
MA Fever	0 0.0%	0 0.0%	0 0.0%

19. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 2.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	182	184	179
Measure Type: Count of Participants; Unit of Measure: Participants
Any Drowsiness	97 53.3%	132 71.7%	109 60.9%
≥ G 2 Drowsiness	31 17.0%	43 23.4%	39 21.8%
G 3 Drowsiness	8 4.4%	7 3.8%	4 2.2%
Rel Drowsiness	94 51.6%	126 68.5%	108 60.3%
G3 Rel Drowsiness	7 3.8%	7 3.8%	3 1.7%
MA Drowsiness	0 0.0%	0 0.0%	0 0.0%
Any Irritability / Fussiness	128 70.3%	147 79.9%	136 76.0%
≥ G 2 Irritability / Fussiness	53 29.1%	70 38.0%	61 34.1%
G 3 Irritability / Fussiness	6 3.3%	14 7.6%	11 6.1%
Rel Irritability / Fussiness	125 68.7%	143 77.7%	133 74.3%
G3 Rel Irritability / Fussiness	6 3.3%	13 7.1%	11 6.1%
MA Irritability / Fussiness	0 0.0%	0 0.0%	2 1.1%
Any Loss of appetite	56 30.8%	55 29.9%	56 31.3%
≥ G 2 Loss of appetite	17 9.3%	15 8.2%	15 8.4%
G 3 Loss of appetite	1 0.5%	1 0.5%	2 1.1%
Rel Loss of appetite	52 28.6%	51 27.7%	55 30.7%
G3 Rel Loss of appetite	1 0.5%	1 0.5%	2 1.1%
MA Loss of appetite	0 0.0%	0 0.0%	1 0.6%
Any Fever	47 25.8%	36 19.6%	35 19.6%
≥ G 2 Fever	2 1.1%	3 1.6%	2 1.1%
G 3 Fever	0 0.0%	0 0.0%	0 0.0%
Rel Fever	37 20.3%	32 17.4%	33 18.4%
G3 Rel Fever	0 0.0%	0 0.0%	0 0.0%
MA Fever	0 0.0%	0 0.0%	0 0.0%

20. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	172	175	170
Measure Type: Count of Participants; Unit of Measure: Participants
Any Drowsiness	85 49.4%	108 61.7%	88 51.8%
≥ G 2 Drowsiness	23 13.4%	37 21.1%	25 14.7%
G 3 Drowsiness	3 1.7%	5 2.9%	9 5.3%
Rel Drowsiness	81 47.1%	105 60.0%	86 50.6%
G3 Rel Drowsiness	3 1.7%	5 2.9%	9 5.3%
MA Drowsiness	0 0.0%	2 1.1%	1 0.6%
Any Irritability / Fussiness	126 73.3%	135 77.1%	122 71.8%
≥ G 2 Irritability / Fussiness	46 26.7%	58 33.1%	58 34.1%
G 3 Irritability / Fussiness	6 3.5%	15 8.6%	11 6.5%
Rel Irritability / Fussiness	121 70.3%	129 73.7%	120 70.6%
G3 Rel Irritability / Fussiness	6 3.5%	13 7.4%	11 6.5%
MA Irritability / Fussiness	0 0.0%	3 1.7%	1 0.6%
Any Loss of appetite	45 26.2%	58 33.1%	53 31.2%
≥ G 2 Loss of appetite	11 6.4%	13 7.4%	15 8.8%
G 3 Loss of appetite	1 0.6%	2 1.1%	2 1.2%
Rel Loss of appetite	44 25.6%	56 32.0%	52 30.6%
G3 Rel Loss of appetite	1 0.6%	2 1.1%	2 1.2%
MA Loss of appetite	0 0.0%	1 0.6%	0 0.0%
Any Fever	40 23.3%	45 25.7%	37 21.8%
≥ G 2 Fever	4 2.3%	11 6.3%	7 4.1%
G 3 Fever	0 0.0%	2 1.1%	0 0.0%
Rel Fever	35 20.3%	39 22.3%	35 20.6%
G3 Rel Fever	0 0.0%	2 1.1%	0 0.0%
MA Fever	1 0.6%	2 1.1%	1 0.6%

21. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time Frame	During the 4-day (Days 0-3) post-vaccination period following any dose.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	187	189	188
Measure Type: Count of Participants; Unit of Measure: Participants
Any Drowsiness	147 78.6%	172 91.0%	168 89.4%
≥ G 2 Drowsiness	67 35.8%	88 46.6%	81 43.1%
G 3 Drowsiness	11 5.9%	19 10.1%	22 11.7%
Rel Drowsiness	144 77.0%	169 89.4%	166 88.3%
G3 Rel Drowsiness	11 5.9%	18 9.5%	21 11.2%
MA Drowsiness	1 0.5%	2 1.1%	1 0.5%
Any Irritability / Fussiness	164 87.7%	182 96.3%	177 94.1%
≥ G 2 Irritability / Fussiness	96 51.3%	128 67.7%	120 63.8%
G 3 Irritability / Fussiness	18 9.6%	35 18.5%	30 16.0%
Rel Irritability / Fussiness	161 86.1%	180 95.2%	175 93.1%
G3 Rel Irritability / Fussiness	18 9.6%	34 18.0%	30 16.0%
MA Irritability / Fussiness	1 0.5%	3 1.6%	3 1.6%
Any Loss of appetite	95 50.8%	111 58.7%	117 62.2%
≥ G 2 Loss of appetite	28 15.0%	32 16.9%	39 20.7%
G 3 Loss of appetite	2 1.1%	3 1.6%	6 3.2%
Rel Loss of appetite	91 48.7%	108 57.1%	116 61.7%
G3 Rel Loss of appetite	2 1.1%	3 1.6%	6 3.2%
MA Loss of appetite	0 0.0%	1 0.5%	1 0.5%
Any Fever	72 38.5%	78 41.3%	72 38.3%
≥ G 2 Fever	6 3.2%	14 7.4%	10 5.3%
G 3 Fever	0 0.0%	2 1.1%	0 0.0%
Rel Fever	61 32.6%	74 39.2%	69 36.7%
G3 Rel Fever	0 0.0%	2 1.1%	0 0.0%
MA Fever	1 0.5%	2 1.1%	1 0.5%

22. Secondary Outcome

Title	Number of Subjects With Specific Adverse Events (AEs).
Description	Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time Frame	From Month 0 up to 6 months post primary-vaccination (Month 10)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	195	194	196
Measure Type: Count of Participants; Unit of Measure: Participants
	7 3.6%	11 5.7%	10 5.1%

23. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs.
Description	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame	During the 31-day (Days 0-30) post-primary vaccination period.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	195	194	196
Measure Type: Count of Participants; Unit of Measure: Participants
	113 57.9%	108 55.7%	96 49.0%

24. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs).
Description	SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame	From Month 0 up to 6 months post-primary vaccination (Month 10)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	195	194	196
Measure Type: Count of Participants; Unit of Measure: Participants
	7 3.6%	1 0.5%	7 3.6%

25. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-T.
Description	A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-T at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		118 90.1%	123 93.2%	107 88.4%
Anti-T at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		138 100.0%	136 100.0%	125 99.2%

26. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-D.
Description	A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-D at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		128 97.7%	123 93.2%	115 95.0%
Anti-D at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		138 100.0%	136 100.0%	126 100.0%

27. Secondary Outcome

Title	Antibody Concentrations for Anti-T.
Description	Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
Anti-T at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		0.327; (0.281 to 0.380)	0.402; (0.340 to 0.474)	0.340; (0.281 to 0.410)
Anti-T at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		9.212; (7.863 to 10.793)	8.870; (7.668 to 10.261)	6.880; (5.905 to 8.015)

28. Secondary Outcome

Title	Antibody Concentrations for Anti-D.
Description	Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
Anti-D at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		0.701; (0.597 to 0.825)	0.622; (0.514 to 0.753)	0.764; (0.629 to 0.928)
Anti-D at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		8.334; (7.479 to 9.286)	7.886; (6.972 to 8.92)	8.537; (7.524 to 9.687)

29. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Description	A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time Frame	At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-PT at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		107 81.7%	114 86.4%	63 52.1%
Anti-FHA at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		130 99.2%	130 98.5%	113 93.4%
Anti-PRN at Visit 5	Number Analyzed	131 participants	132 participants	120 participants
		110 84.0%	104 78.8%	91 75.8%
Anti-PT at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		138 100.0%	136 100.0%	126 100.0%
Anti-FHA at Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		138 100.0%	136 100.0%	126 100.0%
Anti-PRN at Visit 6	Number Analyzed	137 participants	136 participants	125 participants
		136 99.3%	136 100.0%	124 99.2%

30. Secondary Outcome

Title	Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Description	Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time Frame	At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	136	126
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
Anti-PT Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		5.3; (4.6 to 6.2)	6.5; (5.6 to 7.7)	3.1; (2.6 to 3.7)
Anti-FHA Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		17.1; (14.7 to 19.9)	21.8; (18.3 to 26.1)	8.1; (6.6 to 9.9)
Anti-PRN Visit 5	Number Analyzed	131 participants	132 participants	120 participants
		6.8; (5.5 to 8.3)	5.5; (4.5 to 6.6)	6.0; (4.8 to 7.5)
Anti-PT Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		71.4; (62.6 to 81.5)	87.6; (76.6 to 100.2)	55.5; (47.4 to 65.1)
Anti-FHA Visit 6	Number Analyzed	138 participants	136 participants	126 participants
		186.9; (165.1 to 211.5)	250.4; (220.4 to 284.6)	101.0; (86.2 to 118.3)
Anti-PRN Visit 6	Number Analyzed	137 participants	136 participants	125 participants
		208.0; (172.3 to 251.1)	215.6; (176.1 to 263.8)	130.5; (105.9 to 160.9)

31. Secondary Outcome

Title	Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.
Description	Booster response to PT, FHA and PRN antigens was defined as: For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.; For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.; For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration. The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time Frame	At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		131	130	116
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-PT	Number Analyzed	131 participants	130 participants	116 participants
		126 96.2%	121 93.1%	111 95.7%
Anti-FHA	Number Analyzed	131 participants	130 participants	116 participants
		130 99.2%	127 97.7%	114 98.3%
Anti-PRN	Number Analyzed	130 participants	130 participants	115 participants
		128 98.5%	128 98.5%	112 97.4%

32. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-PRP.
Description	A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	139	131
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-PRP at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		91 69.5%	122 92.4%	94 77.7%
Anti-PRP at Visit 6	Number Analyzed	138 participants	139 participants	131 participants
		138 100.0%	139 100.0%	129 98.5%

33. Secondary Outcome

Title	Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
Description	The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	139	131
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-PRP at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		23 17.6%	71 53.8%	47 38.8%
Anti-PRP at Visit 6	Number Analyzed	138 participants	139 participants	131 participants
		136 98.6%	138 99.3%	128 97.7%

34. Secondary Outcome

Title	Antibody Concentrations for Anti-PRP.
Description	Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		138	139	131
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/mL
Anti-PRP at Visit 5	Number Analyzed	131 participants	132 participants	121 participants
		0.301; (0.242 to 0.373)	0.987; (0.775 to 1.256)	0.614; (0.458 to 0.822)
Anti-PRP at Visit 6	Number Analyzed	138 participants	139 participants	131 participants
		39.365; (31.520 to 49.164)	51.140; (41.954 to 62.339)	27.318; (21.140 to 35.302)

35. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
Description	A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		128	129	117
Measure Type: Count of Participants; Unit of Measure: Participants
Anti-polio 1	Number Analyzed	128 participants	128 participants	116 participants
		124 96.9%	121 94.5%	100 86.2%
Anti-polio 2	Number Analyzed	128 participants	128 participants	117 participants
		119 93.0%	122 95.3%	109 93.2%
Anti-polio 3	Number Analyzed	127 participants	129 participants	117 participants
		123 96.9%	126 97.7%	80 68.4%

36. Secondary Outcome

Title	Antibody Titres for Anti-polio Types 1, 2 and 3.
Description	Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		128	129	117
Geometric Mean (95% Confidence Interval); Unit of Measure: titres
Anti-polio 1	Number Analyzed	128 participants	128 participants	116 participants
		99.5; (79.4 to 124.8)	107.4; (83.7 to 137.9)	42.2; (32.6 to 54.6)
Anti-polio 2	Number Analyzed	128 participants	128 participants	117 participants
		94.9; (73.2 to 123.1)	111.9; (88.0 to 142.4)	51.2; (40.8 to 64.3)
Anti-polio 3	Number Analyzed	127 participants	129 participants	117 participants
		122.1; (95.1 to 156.9)	160.4; (125.8 to 204.6)	28.4; (20.6 to 39.1)

37. Secondary Outcome

Title	Number of Seroprotected Subjects Against Anti-HBs.
Description	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	133	131	121
Measure Type: Count of Participants; Unit of Measure: Participants
	131 98.5%	128 97.7%	105 86.8%

38. Secondary Outcome

Title	Antibody Concentrations for Anti-HBs.
Description	Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time Frame	At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	133	131	121
Geometric Mean (95% Confidence Interval); Unit of Measure: mIU/mL
	328.7; (261.5 to 413.2)	235.8; (188.2 to 295.5)	149.4; (100.5 to 222.3)

39. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time Frame	During the 4-day (Days 0-3) post-booster vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.

Arm/Group Title		Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed		154	151	150
Measure Type: Count of Participants; Unit of Measure: Participants
Any Pain, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		61 39.9%	64 42.4%	NA [1]
≥ G 2 Pain, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		11 7.2%	15 9.9%	NA [1]
G 3 Pain, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		1 0.7%	2 1.3%	NA [1]
MA Pain, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		0 0.0%	0 0.0%	NA [1]
Any Pain, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		62 40.3%	74 49.0%	59 39.3%
≥ G2 Pain, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		12 7.8%	19 12.6%	16 10.7%
G3 Pain, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		2 1.3%	3 2.0%	2 1.3%
MA Pain, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		1 0.6%	0 0.0%	0 0.0%
Any Red, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		42 27.5%	49 32.5%	NA [1]
≥ G 2 Red, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		7 4.6%	4 2.6%	NA [1]
G 3 Red, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		0 0.0%	2 1.3%	NA [1]
MA Red, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		0 0.0%	0 0.0%	NA [1]
Any Red, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		49 31.8%	60 39.7%	47 31.3%
≥ G2 Red, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		17 11.0%	14 9.3%	13 8.7%
G3 Red, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		8 5.2%	4 2.6%	2 1.3%
MA Red, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		2 1.3%	0 0.0%	0 0.0%
Any Swe, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		29 19.0%	29 19.2%	NA [1]
≥ G 2 Swe, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		7 4.6%	6 4.0%	NA [1]
G 3 Swe, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		0 0.0%	2 1.3%	NA [1]
MA Swe, ActHIB/Hiberix	Number Analyzed	153 participants	151 participants	150 participants
		0 0.0%	0 0.0%	NA [1]
Any Swe, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		42 27.3%	44 29.1%	35 23.3%
≥ G2 Swe, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		13 8.4%	17 11.3%	14 9.3%
G3 Swe, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		5 3.2%	7 4.6%	4 2.7%
MA Swe, Infanrix/Pentacel	Number Analyzed	154 participants	151 participants	150 participants
		2 1.3%	0 0.0%	0 0.0%

[1]

Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.

40. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time Frame	During the 4-day (Days 0-3) post-booster vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	153	150	151
Measure Type: Count of Participants; Unit of Measure: Participants
Any Drowsiness	59 38.6%	67 44.7%	65 43.0%
≥ G 2 Drowsiness	18 11.8%	20 13.3%	17 11.3%
G 3 Drowsiness	1 0.7%	3 2.0%	2 1.3%
Rel Drowsiness	55 35.9%	65 43.3%	61 40.4%
G3 Rel Drowsiness	1 0.7%	3 2.0%	2 1.3%
MA Drowsiness	0 0.0%	0 0.0%	0 0.0%
Any Irritability / Fussiness	86 56.2%	94 62.7%	76 50.3%
≥ G 2 Irritability / Fussiness	26 17.0%	35 23.3%	23 15.2%
G 3 Irritability / Fussiness	3 2.0%	4 2.7%	4 2.6%
Rel Irritability / Fussiness	85 55.6%	92 61.3%	68 45.0%
G3 Rel Irritability / Fussiness	3 2.0%	4 2.7%	4 2.6%
MA Irritability / Fussiness	0 0.0%	0 0.0%	1 0.7%
Any Loss of appetite	47 30.7%	47 31.3%	46 30.5%
≥ G 2 Loss of appetite	8 5.2%	9 6.0%	11 7.3%
G 3 Loss of appetite	1 0.7%	2 1.3%	2 1.3%
Rel Loss of appetite	44 28.8%	44 29.3%	41 27.2%
G3 Rel Loss of appetite	1 0.7%	2 1.3%	2 1.3%
MA Loss of appetite	0 0.0%	0 0.0%	0 0.0%
Any Fever	4 2.6%	10 6.7%	11 7.3%
≥ G 2 Fever	1 0.7%	1 0.7%	1 0.7%
G 3 Fever	0 0.0%	0 0.0%	0 0.0%
Rel Fever	2 1.3%	10 6.7%	9 6.0%
G3 Rel Fever	0 0.0%	0 0.0%	0 0.0%
MA Fever	0 0.0%	2 1.3%	1 0.7%

41. Secondary Outcome

Title	Number of Subjects With Specific AEs.
Description	Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time Frame	During the 31-day (Days 0-30) post-booster vaccination.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	167	158	161
Measure Type: Count of Participants; Unit of Measure: Participants
	4 2.4%	1 0.6%	1 0.6%

42. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs.
Description	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame	During the 31-day (Days 0-30) post-booster vaccination.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	167	158	161
Measure Type: Count of Participants; Unit of Measure: Participants
	37 22.2%	35 22.2%	41 25.5%

43. Secondary Outcome

Title	Number of Subjects With SAEs.
Description	SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame	During the 31-day (Days 0-30) post-booster vaccination.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Infanrix Hexa Group	Pediarix Group	Pentacel Group
Arm/Group Description:	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Number of Participants Analyzed	167	158	161
Measure Type: Count of Participants; Unit of Measure: Participants
	1 0.6%	0 0.0%	1 0.6%

Adverse Events

Time Frame	Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Infanrix Hexa Group		Pediarix Group		Pentacel Group
Arm/Group Description	Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.		Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
All-Cause Mortality
	Infanrix Hexa Group		Pediarix Group		Pentacel Group
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/195 (0.00%)		0/194 (0.00%)		0/196 (0.00%)
Serious Adverse Events
	Infanrix Hexa Group		Pediarix Group		Pentacel Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/195 (4.10%)		1/194 (0.52%)		8/196 (4.08%)
Blood and lymphatic system disorders
Leukocytosis † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Gastrointestinal disorders
Gastrooesophageal reflux disease † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Infections and infestations
Gastroenteritis viral † 1	1/195 (0.51%)	1	1/194 (0.52%)	1	0/196 (0.00%)	0
Meningitis viral † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Parainfluenzae virus infection † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	2/196 (1.02%)	2
Pneumonia † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Respiratory syncytial virus bronchiolitis † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	1/196 (0.51%)	1
Respiratory syncytial virus infection † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Injury, poisoning and procedural complications
Near drowning † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Road traffic accident † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Metabolism and nutrition disorders
Dehydration † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	1/196 (0.51%)	1
Hyponatraemia † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Nervous system disorders
Febrile convulsion † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Lethargy † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Seizure † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Seizure like phenomena † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Psychiatric disorders
Mental status changes † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Choking † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Hypoxia † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Respiratory distress † 1	3/195 (1.54%)	3	0/194 (0.00%)	0	0/196 (0.00%)	0
Skin and subcutaneous tissue disorders
Petechiae † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
1 Term from vocabulary, MedDRA 20.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Infanrix Hexa Group		Pediarix Group		Pentacel Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	188/195 (96.41%)		190/194 (97.94%)		187/196 (95.41%)
Blood and lymphatic system disorders
Anaemia † 1	1/195 (0.51%)	1	0/194 (0.00%)	0	0/196 (0.00%)	0
Iron deficiency anaemia † 1	0/195 (0.00%)	0	0/194 (0.00%)	0	1/196 (0.51%)	1
Lymphadenopathy † 1	2/195 (1.03%)	2	1/194 (0.52%)	1	0/196 (0.00%)	0
Cardiac disorders
Cyanosis † 1