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Trial record 1 of 2 for:    pediarix | Polio | Phase 3
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Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Infanrix Hexa Group Pediarix Group Pentacel Group Total
Hide 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
Hide 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%
1.Primary Outcome
Title Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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).
Hide 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).
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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)]
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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%
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
Hide 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%)    
Hide 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
Hide 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