Trial Outcomes & Findings for Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants (NCT NCT01000974)

NCT ID: NCT01000974

Last Updated: 2018-07-12

Results Overview

Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4003 participants
• Primary outcome timeframe: At 1 month after last dose of primary vaccination
• Results posted on: 2018-07-12

Participant Flow

Participant milestones

Measure	Hiberix Group Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Primary Vaccination Phase STARTED	2963	520	520
Primary Vaccination Phase COMPLETED	2625	470	457
Primary Vaccination Phase NOT COMPLETED	338	50	63
Booster Vaccination Phase STARTED	2337	435	400
Booster Vaccination Phase COMPLETED	2270	423	386
Booster Vaccination Phase NOT COMPLETED	67	12	14

Reasons for withdrawal

Measure	Hiberix Group Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Primary Vaccination Phase Withdrawal by Subject	109	17	21
Primary Vaccination Phase Lost to Follow-up	171	19	26
Primary Vaccination Phase Protocol Violation	40	3	2
Primary Vaccination Phase Adverse Event	14	2	2
Primary Vaccination Phase Other	4	9	12
Booster Vaccination Phase Protocol Violation	0	0	2
Booster Vaccination Phase Withdrawal by Subject	3	1	1
Booster Vaccination Phase Lost to Follow-up	40	5	7
Booster Vaccination Phase Other	24	6	4

Baseline Characteristics

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

Baseline characteristics by cohort

Measure	Hiberix Group n=2963 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.	Total n=4003 Participants Total of all reporting groups
Age, Continuous	8.6 Weeks STANDARD_DEVIATION 1.08 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.13 • n=7 Participants	8.7 Weeks STANDARD_DEVIATION 1.12 • n=5 Participants	8.61 Weeks STANDARD_DEVIATION 1.09 • n=4 Participants
Sex: Female, Male Female	1424 Participants n=5 Participants	271 Participants n=7 Participants	258 Participants n=5 Participants	1953 Participants n=4 Participants
Sex: Female, Male Male	1539 Participants n=5 Participants	249 Participants n=7 Participants	262 Participants n=5 Participants	2050 Participants n=4 Participants

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).

Outcome measures

Measure	Hiberix Group n=1590 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=274 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=253 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL Anti-PRP ≥ 1.0 µg/mL	1291 Subjects	246 Subjects	198 Subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL Anti-PRP ≥ 0.15 µg/mL	1536 Subjects	265 Subjects	234 Subjects

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.

Outcome measures

Measure	Hiberix Group n=393 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=274 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=250 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-D	393 Subjects	273 Subjects	249 Subjects
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) Anti-T	393 Subjects	274 Subjects	249 Subjects

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).

Outcome measures

Measure	Hiberix Group n=1590 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=274 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=253 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations	5.193 µg/mL Interval 4.765 to 5.658	6.743 µg/mL Interval 5.593 to 8.129	3.640 µg/mL Interval 2.891 to 4.583

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.

Outcome measures

Measure	Hiberix Group n=792 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=275 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=251 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations Anti-FHA	321.8 EL.U/mL Interval 307.0 to 337.3	295.8 EL.U/mL Interval 276.0 to 317.0	174.8 EL.U/mL Interval 160.0 to 191.0
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations Anti-PRN	111.6 EL.U/mL Interval 104.5 to 119.2	93.5 EL.U/mL Interval 83.7 to 104.4	51.9 EL.U/mL Interval 45.4 to 59.3
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations Anti-PT	73.2 EL.U/mL Interval 69.8 to 76.6	71.9 EL.U/mL Interval 66.6 to 77.6	41.9 EL.U/mL Interval 38.4 to 45.8

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

Outcome measures

Measure	Hiberix Group n=389 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=270 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=247 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 1	2.515 µg/mL Interval 2.318 to 2.729	2.500 µg/mL Interval 2.278 to 2.745	2.442 µg/mL Interval 2.19 to 2.722
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 3	1.056 µg/mL Interval 0.976 to 1.142	1.008 µg/mL Interval 0.933 to 1.089	1.190 µg/mL Interval 1.066 to 1.329
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 4	1.804 µg/mL Interval 1.684 to 1.932	1.803 µg/mL Interval 1.662 to 1.957	1.819 µg/mL Interval 1.645 to 2.011
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 5	3.729 µg/mL Interval 3.409 to 4.079	3.656 µg/mL Interval 3.308 to 4.04	3.530 µg/mL Interval 3.128 to 3.984
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 6A	3.442 µg/mL Interval 3.177 to 3.729	3.340 µg/mL Interval 3.032 to 3.679	3.384 µg/mL Interval 3.046 to 3.76
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 6B	1.065 µg/mL Interval 0.95 to 1.196	0.994 µg/mL Interval 0.86 to 1.148	0.875 µg/mL Interval 0.757 to 1.013
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 7F	4.518 µg/mL Interval 4.192 to 4.87	4.115 µg/mL Interval 3.777 to 4.484	3.785 µg/mL Interval 3.412 to 4.199
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 9V	2.516 µg/mL Interval 2.305 to 2.746	2.431 µg/mL Interval 2.204 to 2.681	2.226 µg/mL Interval 1.976 to 2.507
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 14	4.506 µg/mL Interval 4.105 to 4.946	4.111 µg/mL Interval 3.672 to 4.602	3.938 µg/mL Interval 3.472 to 4.466
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 18C	3.655 µg/mL Interval 3.351 to 3.986	3.507 µg/mL Interval 3.196 to 3.848	3.401 µg/mL Interval 3.033 to 3.814
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 19A	1.556 µg/mL Interval 1.433 to 1.689	1.553 µg/mL Interval 1.391 to 1.735	1.321 µg/mL Interval 1.175 to 1.486
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 19F	2.745 µg/mL Interval 2.552 to 2.952	2.833 µg/mL Interval 2.613 to 3.072	2.531 µg/mL Interval 2.315 to 2.766
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations Anti-Pneumoniae 23F	2.046 µg/mL Interval 1.846 to 2.267	1.985 µg/mL Interval 1.765 to 2.232	1.670 µg/mL Interval 1.444 to 1.931

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.

Outcome measures

Measure	Hiberix Group n=792 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=275 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=251 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Anti-PT	764 Subjects	264 Subjects	201 Subjects
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Anti-PRN	762 Subjects	262 Subjects	213 Subjects
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Anti-FHA	744 Subjects	263 Subjects	191 Subjects

PRIMARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).

The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database.

Outcome measures

Measure	Hiberix Group n=280 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=192 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=189 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value Anti-Polio 1	246 Subjects	181 Subjects	164 Subjects
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value Anti-Polio 2	275 Subjects	188 Subjects	183 Subjects
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value Anti-Polio 3	254 Subjects	181 Subjects	168 Subjects

PRIMARY outcome

Timeframe: At 1 month after booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose

Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=236 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL	333 Subjects	231 Subjects	184 Subjects

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).

Outcome measures

Measure	Hiberix Group n=393 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=274 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=250 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations Anti-D	2.72 IU/mL Interval 2.54 to 2.93	2.45 IU/mL Interval 2.24 to 2.68	1.88 IU/mL Interval 1.69 to 2.09
Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations Anti-T	2.23 IU/mL Interval 2.07 to 2.41	2.44 IU/mL Interval 2.2 to 2.71	1.72 IU/mL Interval 1.55 to 1.91

SECONDARY outcome

Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination

Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.

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

Outcome measures

Measure	Hiberix Group n=2846 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=503 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=496 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Solicited Local Symptoms Any swelling	834 Subjects	174 Subjects	195 Subjects
Number of Subjects With Any Solicited Local Symptoms Any pain	1932 Subjects	366 Subjects	370 Subjects
Number of Subjects With Any Solicited Local Symptoms Any redness	1165 Subjects	233 Subjects	257 Subjects

SECONDARY outcome

Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination

Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.

Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).

Outcome measures

Measure	Hiberix Group n=2848 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=503 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=496 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Solicited General Symptoms Any drowsiness	2179 Subjects	398 Subjects	378 Subjects
Number of Subjects With Any Solicited General Symptoms Any loss of appetite	1450 Subjects	275 Subjects	253 Subjects
Number of Subjects With Any Solicited General Symptoms Any irritability	2478 Subjects	449 Subjects	434 Subjects
Number of Subjects With Any Solicited General Symptoms Any fever	1014 Subjects	186 Subjects	143 Subjects

SECONDARY outcome

Timeframe: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination

Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.

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

Outcome measures

Measure	Hiberix Group n=2963 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Unsolicited Adverse Events (AEs).	1880 Subjects	350 Subjects	324 Subjects

SECONDARY outcome

Timeframe: From Day 0 until 6 months following the last primary dose

Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Hiberix Group n=2963 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	108 Subjects	24 Subjects	21 Subjects

SECONDARY outcome

Timeframe: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first

Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Measure	Hiberix Group n=2963 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With AEs of Specific Interest (AESIs)	108 Subjects	22 Subjects	15 Subjects

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.

Outcome measures

Measure	Hiberix Group n=792 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=275 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=251 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA Anti-PT	706 Subjects	248 Subjects	165 Subjects
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA Anti-PRN	741 Subjects	250 Subjects	194 Subjects
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA Anti-FHA	705 Subjects	248 Subjects	166 Subjects

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.

Outcome measures

Measure	Hiberix Group n=792 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=275 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=251 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL Anti-PT	789 Subjects	275 Subjects	249 Subjects
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL Anti-PRN	786 Subjects	275 Subjects	244 Subjects
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL Anti-FHA	791 Subjects	275 Subjects	249 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose

Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=236 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Anti-PRP ≥ 1 µg/mL; PRE vaccination	106 Subjects	61 Subjects	44 Subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Anti-PRP ≥ 1 µg/mL; POST vaccination	333 Subjects	231 Subjects	184 Subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Anti-PRP ≥ 0.15 µg/mL; PRE vaccination	247 Subjects	172 Subjects	116 Subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Anti-PRP ≥ 0.15 µg/mL; POST vaccination	336 Subjects	235 Subjects	186 Subjects

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Hiberix Group n=363 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=258 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=239 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations	3684.3 mIU/mL Interval 3287.0 to 4129.5	3545.6 mIU/mL Interval 3067.8 to 4098.0	1573.4 mIU/mL Interval 1302.6 to 1900.6

SECONDARY outcome

Timeframe: At 1 month after the last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.

Outcome measures

Measure	Hiberix Group n=389 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=270 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=247 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 23F	384 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 1	382 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 3	379 Subjects	268 Subjects	243 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 4	389 Subjects	267 Subjects	247 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 5	377 Subjects	265 Subjects	245 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 6A	379 Subjects	265 Subjects	243 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 6B	351 Subjects	242 Subjects	224 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 7F	386 Subjects	269 Subjects	246 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 9V	385 Subjects	269 Subjects	243 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 14	381 Subjects	265 Subjects	241 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 18C	377 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 19A	379 Subjects	259 Subjects	235 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 19F	383 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.2 µg/mL, Anti-Pneumoniae 23F	376 Subjects	265 Subjects	231 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 1	334 Subjects	239 Subjects	213 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 3	188 Subjects	140 Subjects	138 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 4	318 Subjects	226 Subjects	199 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 5	354 Subjects	250 Subjects	225 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 6A	357 Subjects	253 Subjects	229 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 6B	232 Subjects	151 Subjects	117 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 7F	379 Subjects	264 Subjects	239 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 9V	338 Subjects	234 Subjects	203 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 14	360 Subjects	250 Subjects	223 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 18C	361 Subjects	256 Subjects	229 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 19A	290 Subjects	200 Subjects	164 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 19F	357 Subjects	254 Subjects	231 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 1.0 µg/mL, Anti-Pneumoniae 23F	297 Subjects	208 Subjects	180 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 1	384 Subjects	268 Subjects	245 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 3	382 Subjects	269 Subjects	243 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 4	389 Subjects	268 Subjects	247 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 5	379 Subjects	266 Subjects	246 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 6A	381 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 6B	378 Subjects	260 Subjects	241 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 7F	386 Subjects	269 Subjects	246 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 9V	385 Subjects	270 Subjects	246 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 14	384 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 18C	380 Subjects	267 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 19A	383 Subjects	265 Subjects	244 Subjects
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL ≥ 0.05 µg/mL, Anti-Pneumoniae 19F	384 Subjects	268 Subjects	245 Subjects

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

Antibody titers were given as geometric mean titers(GMTs).

Outcome measures

Measure	Hiberix Group n=478 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=334 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=331 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Antibody Titers for Poliovirus Types 1, 2 and 3 Anti-Polio 1	570.8 Titers Interval 509.2 to 639.8	620.9 Titers Interval 540.1 to 713.7	136.0 Titers Interval 114.7 to 161.1
Antibody Titers for Poliovirus Types 1, 2 and 3 Anti-Polio 2	471.8 Titers Interval 416.7 to 534.1	389.9 Titers Interval 337.3 to 450.6	210.9 Titers Interval 181.9 to 244.5
Antibody Titers for Poliovirus Types 1, 2 and 3 Anti-Polio 3	982.8 Titers Interval 870.1 to 1110.2	963.2 Titers Interval 843.7 to 1099.5	297.4 Titers Interval 253.3 to 349.1

SECONDARY outcome

Timeframe: At 1 month after last dose of primary vaccination

Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.

The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).

Outcome measures

Measure	Hiberix Group n=363 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=258 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=239 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values Anti-HBs≥ 3.3 mIU/ml	362 Subjects	257 Subjects	239 Subjects
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values Anti-HBs≥ 10 mIU/ml	362 Subjects	257 Subjects	239 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=236 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations POST	48.782 µg/mL Interval 42.0 to 56.659	40.293 µg/mL Interval 33.386 to 48.63	37.543 µg/mL Interval 30.535 to 46.158
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations PRE	0.498 µg/mL Interval 0.422 to 0.588	0.467 µg/mL Interval 0.385 to 0.567	0.380 µg/mL Interval 0.299 to 0.484

SECONDARY outcome

Timeframe: Prior to the booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Hiberix Group n=316 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=207 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=167 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL	268.3 mIU/mL Interval 226.7 to 317.5	247.0 mIU/mL Interval 199.8 to 305.3	156.4 mIU/mL Interval 117.9 to 207.5

SECONDARY outcome

Timeframe: Prior to booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose

The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).

Outcome measures

Measure	Hiberix Group n=316 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=207 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=167 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL Anti-HBs ≥ 6.2 mIU/mL	311 Subjects	199 Subjects	156 Subjects
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL Anti-HBs ≥10.0 mIU/mL	306 Subjects	198 Subjects	154 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=235 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-FHA, POST	335 Subjects	235 Subjects	185 Subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-PRN, PRE	279 Subjects	174 Subjects	130 Subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-PRN, POST	331 Subjects	233 Subjects	185 Subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-PT, PRE	243 Subjects	168 Subjects	81 Subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-PT, POST	335 Subjects	235 Subjects	186 Subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL Anti-FHA, PRE	328 Subjects	223 Subjects	171 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.

Outcome measures

Measure	Hiberix Group n=305 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=212 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=168 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 Anti-polio 1	106.2 Titers Interval 91.1 to 123.8	101.6 Titers Interval 84.4 to 122.3	25.1 Titers Interval 20.3 to 31.0
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 Anti-polio 2	109.4 Titers Interval 92.8 to 129.1	89.5 Titers Interval 73.4 to 109.1	48.9 Titers Interval 39.7 to 60.2
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 Anti-polio 3	154.8 Titers Interval 129.3 to 185.3	151.9 Titers Interval 122.4 to 188.5	40.6 Titers Interval 31.4 to 52.5

SECONDARY outcome

Timeframe: Prior to booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.

Outcome measures

Measure	Hiberix Group n=305 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=212 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=168 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 Anti-polio 1	294 Subjects	197 Subjects	124 Subjects
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 Anti-polio 2	285 Subjects	196 Subjects	144 Subjects
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 Anti-polio 3	283 Subjects	201 Subjects	130 Subjects

SECONDARY outcome

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.

Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=236 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-D≥ 0.1 IU/mL, PRE	322 Subjects	218 Subjects	173 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-D≥ 0.1 IU/mL, POST	336 Subjects	236 Subjects	186 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-T≥ 0.1 IU/mL, POST	336 Subjects	236 Subjects	186 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-T≥ 0.1 IU/mL, PRE	292 Subjects	196 Subjects	154 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-D≥1.0 IU/mL , PRE	151 Subjects	89 Subjects	70 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-D≥1.0 IU/mL , POST	334 Subjects	234 Subjects	186 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-T≥1.0 IU/mL , PRE	52 Subjects	27 Subjects	14 Subjects
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. Anti-T≥1.0 IU/mL , POST	330 Subjects	233 Subjects	180 Subjects

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) following the booster dose

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.

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

Outcome measures

Measure	Hiberix Group n=2224 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=416 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=379 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Solicited Local Symptoms Any Pain	918 Subjects	179 Subjects	163 Subjects
Number of Subjects With Any Solicited Local Symptoms Any Redness	659 Subjects	127 Subjects	115 Subjects
Number of Subjects With Any Solicited Local Symptoms Any Swelling	392 Subjects	82 Subjects	75 Subjects

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) following the booster dose

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.

Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).

Outcome measures

Measure	Hiberix Group n=2225 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=416 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=379 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	857 Subjects	164 Subjects	119 Subjects
Number of Subjects With Any Solicited General Symptoms Any Irritability	1293 Subjects	250 Subjects	201 Subjects
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	614 Subjects	141 Subjects	85 Subjects
Number of Subjects With Any Solicited General Symptoms Any Fever	119 Subjects	18 Subjects	20 Subjects

SECONDARY outcome

Timeframe: From booster dose until 6 months following receipt of the booster dose

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Measure	Hiberix Group n=2337 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=435 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=400 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With AEs of Specific Interest (AESIs)	47 Subjects	12 Subjects	7 Subjects

SECONDARY outcome

Timeframe: Within 31 days (Day 0 to Day 30) following the booster dose

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.

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

Outcome measures

Measure	Hiberix Group n=2337 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=435 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=400 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Any Unsolicited Adverse Events (AEs).	882 Subjects	159 Subjects	138 Subjects

SECONDARY outcome

Timeframe: From the booster dose until 6 months following receipt of the booster dose

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Hiberix Group n=2337 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=435 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=400 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	29 Subjects	4 Subjects	2 Subjects

SECONDARY outcome

Timeframe: pre-booster and one month after booster vaccination

Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose

Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.

Outcome measures

Measure	Hiberix Group n=336 Participants Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=235 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=186 Participants Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-PRN, PRE	13.3 EL.U/mL Interval 12.0 to 14.8	11.2 EL.U/mL Interval 9.8 to 12.9	9.7 EL.U/mL Interval 8.3 to 11.3
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-PT, PRE	8.5 EL.U/mL Interval 7.7 to 9.3	8.6 EL.U/mL Interval 7.7 to 9.7	4.8 EL.U/mL Interval 4.2 to 5.3
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-PT, POST	90.9 EL.U/mL Interval 83.9 to 98.4	93.1 EL.U/mL Interval 84.1 to 103.1	75.3 EL.U/mL Interval 66.7 to 85.1
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-FHA, PRE	41.3 EL.U/mL Interval 37.4 to 45.6	40.0 EL.U/mL Interval 35.2 to 45.5	22.7 EL.U/mL Interval 20.0 to 25.7
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-FHA, POST	464.9 EL.U/mL Interval 430.0 to 502.7	492.5 EL.U/mL Interval 449.0 to 540.3	263.8 EL.U/mL Interval 239.5 to 290.5
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations Anti-PRN, POST	288.9 EL.U/mL Interval 260.4 to 320.5	259.2 EL.U/mL Interval 225.6 to 297.7	153.2 EL.U/mL Interval 128.5 to 182.6

Adverse Events

Hiberix Group

Serious events: 120 serious events

Other events: 2783 other events

Deaths: 0 deaths

ActHIB Group

Serious events: 24 serious events

Other events: 495 other events

Deaths: 0 deaths

Pentacel Group

Serious events: 21 serious events

Other events: 488 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hiberix Group n=2963 participants at risk Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 participants at risk Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 participants at risk Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Infections and infestations Bronchiolitis	0.54% 16/2963 • Number of events 16 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Diarrhoea	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Gastrooesophageal reflux disease	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Haematemesis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Intussusception	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Mallory-weiss syndrome	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Vomiting	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
General disorders Developmental delay	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
General disorders Pyrexia	0.17% 5/2963 • Number of events 5 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Immune system disorders Anaphylactic shock	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Abscess neck	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Cellulitis	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Croup infectious	0.13% 4/2963 • Number of events 4 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Gastroenteritis	0.10% 3/2963 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Gastroenteritis viral	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Groin abscess	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Influenza	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Mastoiditis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Meningitis streptococcal	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Otitis media	0.34% 10/2963 • Number of events 10 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Pertussis	0.10% 3/2963 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Pneumonia	0.47% 14/2963 • Number of events 14 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Pyelonephritis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Pyelonephritis acute	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Respiratory syncytial virus bronchiolitis	0.44% 13/2963 • Number of events 13 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.77% 4/520 • Number of events 4 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Respiratory syncytial virus infection	0.30% 9/2963 • Number of events 9 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Sinusitis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Staphylococcal abscess	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Streptococcal bacteraemia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Subcutaneous abscess	0.10% 3/2963 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Upper respiratory tract infection	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Urinary tract infection	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Viral infection	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Viral rash	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Child maltreatment syndrome	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Extradural haematoma	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Femur fracture	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Foreign body	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Foreign body aspiration	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Rib fracture	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Skull fracture	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Injury, poisoning and procedural complications Subdural haemorrhage	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Dehydration	0.34% 10/2963 • Number of events 10 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.58% 3/520 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Failure to thrive	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Hyperkalaemia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Hypoglycaemia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Weight gain poor	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Musculoskeletal and connective tissue disorders Growth retardation	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of skin	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Convulsion	0.13% 4/2963 • Number of events 4 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Drooling	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Dyskinesia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Encephalopathy	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Epilepsy	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Febrile convulsion	0.27% 8/2963 • Number of events 8 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.58% 3/520 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Muscle contractions involuntary	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Myoclonus	0.03% 1/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Sympathomimetic effect	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Psychiatric disorders Autism spectrum disorder	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Renal and urinary disorders Vesicoureteric reflux	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.10% 3/2963 • Number of events 3 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Choking	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.17% 5/2963 • Number of events 5 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.38% 2/520 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Vascular disorders Kawasaki's disease	0.07% 2/2963 • Number of events 2 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Congenital nystagmus	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Blood and lymphatic system disorders Anaemia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Blood and lymphatic system disorders Lymphadenitis	0.13% 4/2963 • Number of events 4 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Blood and lymphatic system disorders Neutropenia	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Cardiac disorders Cyanosis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Congenital aplastic anaemia	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Congenital retinoblastoma	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Microcephaly	0.00% 0/2963 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Mitochondrial dna mutation	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Congenital, familial and genetic disorders Pyloric stenosis	0.03% 1/2963 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.00% 0/520 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	0.19% 1/520 • Number of events 1 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively

Other adverse events

Measure	Hiberix Group n=2963 participants at risk Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	ActHIB Group n=520 participants at risk Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.	Pentacel Group n=520 participants at risk Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
Infections and infestations Bronchiolitis	4.0% 120/2963 • Number of events 123 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	3.8% 20/520 • Number of events 21 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	5.0% 26/520 • Number of events 26 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Eye disorders Conjunctivitis	3.6% 108/2963 • Number of events 114 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	5.6% 29/520 • Number of events 30 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	4.4% 23/520 • Number of events 25 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Cough	12.5% 369/2963 • Number of events 427 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	12.3% 64/520 • Number of events 71 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	14.0% 73/520 • Number of events 89 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Metabolism and nutrition disorders Decreased appetite	53.9% 1596/2963 • Number of events 2761 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	58.5% 304/520 • Number of events 561 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	52.3% 272/520 • Number of events 460 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Diarrhoea	7.2% 212/2963 • Number of events 231 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	6.9% 36/520 • Number of events 39 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	5.4% 28/520 • Number of events 34 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Skin and subcutaneous tissue disorders Erythema	44.1% 1306/2963 • Number of events 2465 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	50.4% 262/520 • Number of events 506 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	53.3% 277/520 • Number of events 525 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Psychiatric disorders Irritability	85.2% 2525/2963 • Number of events 6600 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	88.3% 459/520 • Number of events 1257 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	84.8% 441/520 • Number of events 1151 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.8% 171/2963 • Number of events 195 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	6.3% 33/520 • Number of events 38 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	6.9% 36/520 • Number of events 41 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Otitis media	12.0% 355/2963 • Number of events 420 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	12.1% 63/520 • Number of events 76 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	11.7% 61/520 • Number of events 79 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
General disorders Pain	68.7% 2035/2963 • Number of events 4407 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	73.1% 380/520 • Number of events 906 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	73.7% 383/520 • Number of events 864 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
General disorders Pyrexia	43.5% 1288/2963 • Number of events 1946 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	46.2% 240/520 • Number of events 360 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	38.7% 201/520 • Number of events 294 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 210/2963 • Number of events 241 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	8.7% 45/520 • Number of events 50 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	8.1% 42/520 • Number of events 45 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Nervous system disorders Somnolence	75.4% 2235/2963 • Number of events 5051 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	78.7% 409/520 • Number of events 960 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	74.4% 387/520 • Number of events 858 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
General disorders Swelling	31.9% 944/2963 • Number of events 1547 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	36.7% 191/520 • Number of events 348 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	40.6% 211/520 • Number of events 370 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Teething	5.5% 164/2963 • Number of events 204 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	5.8% 30/520 • Number of events 31 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	6.5% 34/520 • Number of events 41 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Infections and infestations Upper respiratory tract infection	22.1% 655/2963 • Number of events 787 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	21.0% 109/520 • Number of events 129 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	20.2% 105/520 • Number of events 124 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively
Gastrointestinal disorders Vomiting	6.7% 200/2963 • Number of events 231 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	6.9% 36/520 • Number of events 36 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively	5.6% 29/520 • Number of events 31 • SAEs= Day 0 to 6 months following last primary dose and from booster dose until 6 months after receipt of booster dose. Systematically and non-systematically assessed frequent AEs=within 4 and 31 days following primary and booster vaccination respectively

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER