Trial Outcomes & Findings for Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants (NCT NCT02096263)

NCT ID: NCT02096263

Last Updated: 2019-11-27

Results Overview

Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 585 participants
• Primary outcome timeframe: At Month 5, one month after the third dose of the primary vaccination.
• Results posted on: 2019-11-27

Participant Flow

This study was conducted in 43 centers in the United States of America (USA).

Participant milestones

Measure	Infanrix Hexa Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Study STARTED	195	194	196
Overall Study COMPLETED	161	158	157
Overall Study NOT COMPLETED	34	36	39

Reasons for withdrawal

Measure	Infanrix Hexa Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Overall Study Adverse Event	1	0	1
Overall Study Lost to Follow-up	14	18	15
Overall Study Other	7	9	6
Overall Study Sponsor study termination	0	0	1
Overall Study Protocol Violation	7	2	8
Overall Study Withdrawal by Subject	5	7	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Infanrix Hexa Group n=195 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Total n=585 Participants Total of all reporting groups
Age, Continuous	8.5 Weeks STANDARD_DEVIATION 1.0 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.1 • n=7 Participants	8.6 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 1.1 • n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	80 Participants n=7 Participants	95 Participants n=5 Participants	276 Participants n=4 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	114 Participants n=7 Participants	101 Participants n=5 Participants	309 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized African Heritage / African American	16 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants	45 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	118 Participants n=5 Participants	128 Participants n=7 Participants	115 Participants n=5 Participants	361 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unspecified	29 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants	88 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	15 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	47 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination.

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

Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.

Outcome measures

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

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination.

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

A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.

Outcome measures

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

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination.

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

A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=146 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=149 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=149 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Tetanus (T).	146 Participants	149 Participants	148 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination.

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

A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=142 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=144 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=149 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Diphtheria (D).	142 Participants	144 Participants	149 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=146 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=149 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=149 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Antibody Concentrations for Anti-T.	2.458 IU/mL Interval 2.195 to 2.753	2.633 IU/mL Interval 2.338 to 2.966	2.012 IU/mL Interval 1.768 to 2.29

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.

Outcome measures

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

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.

Outcome measures

Measure	Infanrix Hexa Group n=137 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=134 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 1	137 Participants	134 Participants	135 Participants
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 2	133 Participants	131 Participants	134 Participants
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 3	129 Participants	132 Participants	124 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.

Outcome measures

Measure	Infanrix Hexa Group n=137 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=134 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Antibody Titres for Anti-polio Types 1, 2 and 3. Anti-polio 1	546.9 titres Interval 447.7 to 668.0	604.1 titres Interval 495.9 to 736.0	319.5 titres Interval 256.8 to 397.5
Antibody Titres for Anti-polio Types 1, 2 and 3. Anti-polio 2	483.5 titres Interval 394.2 to 593.0	567.7 titres Interval 448.8 to 718.1	283.0 titres Interval 229.4 to 349.2
Antibody Titres for Anti-polio Types 1, 2 and 3. Anti-polio 3	722.2 titres Interval 577.4 to 903.4	927.0 titres Interval 740.7 to 1160.3	294.6 titres Interval 221.6 to 391.7

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.

Outcome measures

Measure	Infanrix Hexa Group n=154 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=154 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=156 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).	146 Participants	151 Participants	154 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.

Outcome measures

Measure	Infanrix Hexa Group n=154 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=154 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=156 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.	85 Participants	145 Participants	130 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.

Outcome measures

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

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).

Outcome measures

Measure	Infanrix Hexa Group n=134 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).	134 Participants	138 Participants	133 Participants

SECONDARY outcome

Timeframe: At Month 5, one month after the third dose of the primary vaccination

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

Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.

Outcome measures

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

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 1

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

The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

Outcome measures

Measure	Infanrix Hexa Group n=185 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=189 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=188 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited Local Symptoms. Any Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	123 Participants	100 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	66 Participants	45 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	22 Participants	10 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain, Infanrix hexa/Pediarix/Pentacel	94 Participants	113 Participants	115 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, Infanrix hexa/Pediarix/Pentacel	40 Participants	65 Participants	51 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Pain, Infanrix hexa/Pediarix/Pentacel	8 Participants	17 Participants	12 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, Infanrix hexa/Pediarix/Pentacel	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	63 Participants	55 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	19 Participants	12 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	8 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms. MA Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Redness, Infanrix hexa/Pediarix/Pentacel	47 Participants	56 Participants	57 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Redness, Infanrix hexa/Pediarix/Pentacel	15 Participants	15 Participants	20 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Redness, Infanrix hexa/Pediarix/Pentacel	3 Participants	4 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. MA Redness, Infanrix hexa/Pediarix/Pentacel	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	41 Participants	39 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	14 Participants	14 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	6 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. MA Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swelling, Infanrix hexa/Pediarix/Pentacel	31 Participants	35 Participants	45 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swelling, Infanrix hexa/Pediarix/Pentacel	10 Participants	14 Participants	24 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swelling, Infanrix hexa/Pediarix/Pentacel	2 Participants	3 Participants	11 Participants
Number of Subjects With Solicited Local Symptoms. MA Swelling, Infanrix hexa/Pediarix/Pentacel	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 2

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

The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

Outcome measures

Measure	Infanrix Hexa Group n=182 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=184 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=180 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited Local Symptoms. Any Red, Infanrix/Pediarix/Pentacel	59 Participants	61 Participants	64 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	104 Participants	6 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	47 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	9 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain,Infanrix/Pediarix/Pentacel	84 Participants	108 Participants	93 Participants
Number of Subjects With Solicited Local Symptoms. ≥G2 Pain,Infanrix/Pediarix/Pentacel	25 Participants	44 Participants	31 Participants
Number of Subjects With Solicited Local Symptoms. G3 Pain,Infanrix/Pediarix/Pentacel	1 Participants	7 Participants	6 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, Infanrix/Pediarix/Pentacel	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	66 Participants	5 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	17 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Redness, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. ≥G2 Red,Infanrix/Pediarix/Pentacel	15 Participants	12 Participants	15 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Red, Infanrix/Pediarix/Pentacel	3 Participants	3 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, Infanrix/Pediarix/Pentacel	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	40 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	11 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Swelling, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, Infanrix/Pediarix/Pentacel	41 Participants	40 Participants	42 Participants
Number of Subjects With Solicited Local Symptoms. ≥G2 Swe, Infanrix/Pediarix/Pentacel	10 Participants	12 Participants	7 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swe, Infanrix/Pediarix/Pentacel	2 Participants	2 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, Infanrix/Pediarix/Pentacel	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 3

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

The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA

Outcome measures

Measure	Infanrix Hexa Group n=172 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=175 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=171 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	7 Participants	9 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Red, Infanrix/Pediarix/Pentacel	63 Participants	66 Participants	56 Participants
Number of Subjects With Solicited Local Symptoms. ≥G2 Red, Infanrix/Pediarix/Pentacel	7 Participants	12 Participants	11 Participants
Number of Subjects With Solicited Local Symptoms. G3 Red, Infanrix/Pediarix/Pentacel	1 Participants	3 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, Infanrix/Pediarix/Pentacel	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	42 Participants	37 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	7 Participants	7 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, Infanrix/Pediarix/Pentacel	43 Participants	44 Participants	35 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Swe, Infanrix/Pediarix/Pentacel	7 Participants	10 Participants	4 Participants
Number of Subjects With Solicited Local Symptoms. G3 Swe, Infanrix/Pediarix/Pentacel	1 Participants	3 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, Infanrix/Pediarix/Pentacel	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, Infanrix/Pediarix/Pentacel	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	93 Participants	75 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	41 Participants	25 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	7 Participants	5 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain, Infanrix/Pediarix/Pentacel	67 Participants	90 Participants	76 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Pain, Infanrix/Pediarix/Pentacel	18 Participants	39 Participants	20 Participants
Number of Subjects With Solicited Local Symptoms. G3 Pain, Infanrix/Pediarix/Pentacel	0 Participants	7 Participants	7 Participants
Number of Subjects With Solicited Local Symptoms. Any Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	69 Participants	51 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following any dose.

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

The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

Outcome measures

Measure	Infanrix Hexa Group n=187 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=189 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=188 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited Local Symptoms. Any Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	148 Participants	127 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	96 Participants	62 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	30 Participants	14 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	2 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Pain, Infanrix/Pediarix/Pentacel	127 Participants	151 Participants	147 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Pain, Infanrix/Pediarix/Pentacel	58 Participants	93 Participants	80 Participants
Number of Subjects With Solicited Local Symptoms. G3 Pain, Infanrix/Pediarix/Pentacel	8 Participants	27 Participants	22 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, Infanrix/Pediarix/Pentacel	1 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	108 Participants	77 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	38 Participants	20 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	10 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Red, Infanrix/Pediarix/Pentacel	94 Participants	98 Participants	87 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Red, Infanrix/Pediarix/Pentacel	27 Participants	32 Participants	37 Participants
Number of Subjects With Solicited Local Symptoms. G3 Red, Infanrix/Pediarix/Pentacel	7 Participants	9 Participants	5 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, Infanrix/Pediarix/Pentacel	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	78 Participants	64 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	25 Participants	18 Participants
Number of Subjects With Solicited Local Symptoms. G 3 Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	7 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, ActHIB/Engerix	NA Participants Subjects in Infanrix hexa Group did not receive the ActHIB or Engerix vaccines.	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, Infanrix/Pediarix/Pentacel	73 Participants	70 Participants	72 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Swe, Infanrix/Pediarix/Pentacel	20 Participants	26 Participants	26 Participants
Number of Subjects With Solicited Local Symptoms. G3 Swe, Infanrix/Pediarix/Pentacel	4 Participants	7 Participants	12 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, Infanrix/Pediarix/Pentacel	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 1.

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

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

Outcome measures

Measure	Infanrix Hexa Group n=185 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=189 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=188 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Any Drowsiness	114 Participants	143 Participants	149 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Drowsiness	36 Participants	56 Participants	53 Participants
Number of Subjects With Solicited General Symptoms. G 3 Drowsiness	3 Participants	8 Participants	12 Participants
Number of Subjects With Solicited General Symptoms. Rel Drowsiness	112 Participants	136 Participants	141 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Drowsiness	3 Participants	7 Participants	12 Participants
Number of Subjects With Solicited General Symptoms. MA Drowsiness	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Irritability / Fussiness	115 Participants	165 Participants	153 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Irritability / Fussiness	42 Participants	79 Participants	68 Participants
Number of Subjects With Solicited General Symptoms. G 3 Irritability / Fussiness	9 Participants	17 Participants	15 Participants
Number of Subjects With Solicited General Symptoms. Rel Irritability / Fussiness	113 Participants	163 Participants	147 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Irritability / Fussiness	9 Participants	17 Participants	15 Participants
Number of Subjects With Solicited General Symptoms. MA Irritability / Fussiness	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Loss of appetite	53 Participants	76 Participants	80 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Loss of appetite	8 Participants	13 Participants	26 Participants
Number of Subjects With Solicited General Symptoms. G 3 Loss of appetite	0 Participants	1 Participants	4 Participants
Number of Subjects With Solicited General Symptoms. Rel Loss of appetite	48 Participants	73 Participants	77 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Loss of appetite	0 Participants	1 Participants	4 Participants
Number of Subjects With Solicited General Symptoms. MA Loss of appetite	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	22 Participants	34 Participants	29 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Fever	0 Participants	0 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. G 3 Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Rel Fever	15 Participants	31 Participants	27 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. MA Fever	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 2.

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

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

Outcome measures

Measure	Infanrix Hexa Group n=182 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=184 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=179 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Any Drowsiness	97 Participants	132 Participants	109 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Drowsiness	31 Participants	43 Participants	39 Participants
Number of Subjects With Solicited General Symptoms. G 3 Drowsiness	8 Participants	7 Participants	4 Participants
Number of Subjects With Solicited General Symptoms. Rel Drowsiness	94 Participants	126 Participants	108 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Drowsiness	7 Participants	7 Participants	3 Participants
Number of Subjects With Solicited General Symptoms. MA Drowsiness	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Irritability / Fussiness	128 Participants	147 Participants	136 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Irritability / Fussiness	53 Participants	70 Participants	61 Participants
Number of Subjects With Solicited General Symptoms. G 3 Irritability / Fussiness	6 Participants	14 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. Rel Irritability / Fussiness	125 Participants	143 Participants	133 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Irritability / Fussiness	6 Participants	13 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. MA Irritability / Fussiness	0 Participants	0 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. Any Loss of appetite	56 Participants	55 Participants	56 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Loss of appetite	17 Participants	15 Participants	15 Participants
Number of Subjects With Solicited General Symptoms. G 3 Loss of appetite	1 Participants	1 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. Rel Loss of appetite	52 Participants	51 Participants	55 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Loss of appetite	1 Participants	1 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. MA Loss of appetite	0 Participants	0 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	47 Participants	36 Participants	35 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Fever	2 Participants	3 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. G 3 Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Rel Fever	37 Participants	32 Participants	33 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. MA Fever	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following Dose 3.

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

The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.

Outcome measures

Measure	Infanrix Hexa Group n=172 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=175 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=170 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Any Drowsiness	85 Participants	108 Participants	88 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Drowsiness	23 Participants	37 Participants	25 Participants
Number of Subjects With Solicited General Symptoms. G 3 Drowsiness	3 Participants	5 Participants	9 Participants
Number of Subjects With Solicited General Symptoms. Rel Drowsiness	81 Participants	105 Participants	86 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Drowsiness	3 Participants	5 Participants	9 Participants
Number of Subjects With Solicited General Symptoms. MA Drowsiness	0 Participants	2 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Irritability / Fussiness	126 Participants	135 Participants	122 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Irritability / Fussiness	46 Participants	58 Participants	58 Participants
Number of Subjects With Solicited General Symptoms. G 3 Irritability / Fussiness	6 Participants	15 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. Rel Irritability / Fussiness	121 Participants	129 Participants	120 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Irritability / Fussiness	6 Participants	13 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. MA Irritability / Fussiness	0 Participants	3 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Loss of appetite	45 Participants	58 Participants	53 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Loss of appetite	11 Participants	13 Participants	15 Participants
Number of Subjects With Solicited General Symptoms. G 3 Loss of appetite	1 Participants	2 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. Rel Loss of appetite	44 Participants	56 Participants	52 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Loss of appetite	1 Participants	2 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. MA Loss of appetite	0 Participants	1 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	40 Participants	45 Participants	37 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Fever	4 Participants	11 Participants	7 Participants
Number of Subjects With Solicited General Symptoms. G 3 Fever	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Rel Fever	35 Participants	39 Participants	35 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Fever	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. MA Fever	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following any dose.

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

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

Outcome measures

Measure	Infanrix Hexa Group n=187 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=189 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=188 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Any Drowsiness	147 Participants	172 Participants	168 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Drowsiness	67 Participants	88 Participants	81 Participants
Number of Subjects With Solicited General Symptoms. G 3 Drowsiness	11 Participants	19 Participants	22 Participants
Number of Subjects With Solicited General Symptoms. Rel Drowsiness	144 Participants	169 Participants	166 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Drowsiness	11 Participants	18 Participants	21 Participants
Number of Subjects With Solicited General Symptoms. MA Drowsiness	1 Participants	2 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Irritability / Fussiness	164 Participants	182 Participants	177 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Irritability / Fussiness	96 Participants	128 Participants	120 Participants
Number of Subjects With Solicited General Symptoms. G 3 Irritability / Fussiness	18 Participants	35 Participants	30 Participants
Number of Subjects With Solicited General Symptoms. Rel Irritability / Fussiness	161 Participants	180 Participants	175 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Irritability / Fussiness	18 Participants	34 Participants	30 Participants
Number of Subjects With Solicited General Symptoms. MA Irritability / Fussiness	1 Participants	3 Participants	3 Participants
Number of Subjects With Solicited General Symptoms. Any Loss of appetite	95 Participants	111 Participants	117 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Loss of appetite	28 Participants	32 Participants	39 Participants
Number of Subjects With Solicited General Symptoms. G 3 Loss of appetite	2 Participants	3 Participants	6 Participants
Number of Subjects With Solicited General Symptoms. Rel Loss of appetite	91 Participants	108 Participants	116 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Loss of appetite	2 Participants	3 Participants	6 Participants
Number of Subjects With Solicited General Symptoms. MA Loss of appetite	0 Participants	1 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	72 Participants	78 Participants	72 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Fever	6 Participants	14 Participants	10 Participants
Number of Subjects With Solicited General Symptoms. G 3 Fever	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Rel Fever	61 Participants	74 Participants	69 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Fever	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. MA Fever	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From Month 0 up to 6 months post primary-vaccination (Month 10)

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

Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)

Outcome measures

Measure	Infanrix Hexa Group n=195 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Specific Adverse Events (AEs).	7 Participants	11 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-primary vaccination period.

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

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

Measure	Infanrix Hexa Group n=195 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Unsolicited AEs.	113 Participants	108 Participants	96 Participants

SECONDARY outcome

Timeframe: From Month 0 up to 6 months post-primary vaccination (Month 10)

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

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	Infanrix Hexa Group n=195 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Serious Adverse Events (SAEs).	7 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]

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

A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=126 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-T. Anti-T at Visit 5	118 Participants	123 Participants	107 Participants
Number of Seroprotected Subjects Against Anti-T. Anti-T at Visit 6	138 Participants	136 Participants	125 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]

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

A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=126 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-D. Anti-D at Visit 5	128 Participants	123 Participants	115 Participants
Number of Seroprotected Subjects Against Anti-D. Anti-D at Visit 6	138 Participants	136 Participants	126 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

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

Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=126 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Antibody Concentrations for Anti-T. Anti-T at Visit 5	0.327 IU/mL Interval 0.281 to 0.38	0.402 IU/mL Interval 0.34 to 0.474	0.340 IU/mL Interval 0.281 to 0.41
Antibody Concentrations for Anti-T. Anti-T at Visit 6	9.212 IU/mL Interval 7.863 to 10.793	8.870 IU/mL Interval 7.668 to 10.261	6.880 IU/mL Interval 5.905 to 8.015

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

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

Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.

Outcome measures

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

SECONDARY outcome

Timeframe: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]

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

A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=136 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=126 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT at Visit 5	107 Participants	114 Participants	63 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA at Visit 5	130 Participants	130 Participants	113 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN at Visit 5	110 Participants	104 Participants	91 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT at Visit 6	138 Participants	136 Participants	126 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA at Visit 6	138 Participants	136 Participants	126 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN at Visit 6	136 Participants	136 Participants	124 Participants

SECONDARY outcome

Timeframe: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]

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

Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.

Outcome measures

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

SECONDARY outcome

Timeframe: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

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

Booster response to PT, FHA and PRN antigens was defined as:

• For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.
• For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.
• For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration.

The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.

Outcome measures

Measure	Infanrix Hexa Group n=131 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=130 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=116 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT	126 Participants	121 Participants	111 Participants
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA	130 Participants	127 Participants	114 Participants
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN	128 Participants	128 Participants	112 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]

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

A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=139 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=131 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-PRP. Anti-PRP at Visit 5	91 Participants	122 Participants	94 Participants
Number of Seroprotected Subjects Against Anti-PRP. Anti-PRP at Visit 6	138 Participants	139 Participants	129 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]

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

The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=139 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=131 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. Anti-PRP at Visit 5	23 Participants	71 Participants	47 Participants
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. Anti-PRP at Visit 6	136 Participants	138 Participants	128 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]

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

Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.

Outcome measures

Measure	Infanrix Hexa Group n=138 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=139 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=131 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Antibody Concentrations for Anti-PRP. Anti-PRP at Visit 5	0.301 µg/mL Interval 0.242 to 0.373	0.987 µg/mL Interval 0.775 to 1.256	0.614 µg/mL Interval 0.458 to 0.822
Antibody Concentrations for Anti-PRP. Anti-PRP at Visit 6	39.365 µg/mL Interval 31.52 to 49.164	51.140 µg/mL Interval 41.954 to 62.339	27.318 µg/mL Interval 21.14 to 35.302

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

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

A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.

Outcome measures

Measure	Infanrix Hexa Group n=128 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=129 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=117 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 1	124 Participants	121 Participants	100 Participants
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 2	119 Participants	122 Participants	109 Participants
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. Anti-polio 3	123 Participants	126 Participants	80 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

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

Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.

Outcome measures

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

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

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

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Outcome measures

Measure	Infanrix Hexa Group n=133 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=131 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=121 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Seroprotected Subjects Against Anti-HBs.	131 Participants	128 Participants	105 Participants

SECONDARY outcome

Timeframe: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]

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

Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.

Outcome measures

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

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-booster vaccination.

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

The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

Outcome measures

Measure	Infanrix Hexa Group n=154 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=151 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=150 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited Local Symptoms. Any Pain, ActHIB/Hiberix	61 Participants	64 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Pain, ActHIB/Hiberix	11 Participants	15 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. G 3 Pain, ActHIB/Hiberix	1 Participants	2 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. MA Pain, ActHIB/Hiberix	0 Participants	0 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. Any Pain, Infanrix/Pentacel	62 Participants	74 Participants	59 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Pain, Infanrix/Pentacel	12 Participants	19 Participants	16 Participants
Number of Subjects With Solicited Local Symptoms. G3 Pain, Infanrix/Pentacel	2 Participants	3 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms. MA Pain, Infanrix/Pentacel	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Red, ActHIB/Hiberix	42 Participants	49 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Red, ActHIB/Hiberix	7 Participants	4 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. G 3 Red, ActHIB/Hiberix	0 Participants	2 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. MA Red, ActHIB/Hiberix	0 Participants	0 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. Any Red, Infanrix/Pentacel	49 Participants	60 Participants	47 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Red, Infanrix/Pentacel	17 Participants	14 Participants	13 Participants
Number of Subjects With Solicited Local Symptoms. G3 Red, Infanrix/Pentacel	8 Participants	4 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms. MA Red, Infanrix/Pentacel	2 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swe, ActHIB/Hiberix	29 Participants	29 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. ≥ G 2 Swe, ActHIB/Hiberix	7 Participants	6 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. G 3 Swe, ActHIB/Hiberix	0 Participants	2 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. MA Swe, ActHIB/Hiberix	0 Participants	0 Participants	NA Participants Subjects in Pentacel Group did not receive the ActHIB or Hiberix vaccines.
Number of Subjects With Solicited Local Symptoms. Any Swe, Infanrix/Pentacel	42 Participants	44 Participants	35 Participants
Number of Subjects With Solicited Local Symptoms. ≥ G2 Swe, Infanrix/Pentacel	13 Participants	17 Participants	14 Participants
Number of Subjects With Solicited Local Symptoms. G3 Swe, Infanrix/Pentacel	5 Participants	7 Participants	4 Participants
Number of Subjects With Solicited Local Symptoms. MA Swe, Infanrix/Pentacel	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-booster vaccination.

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

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

Outcome measures

Measure	Infanrix Hexa Group n=153 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=150 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=151 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Any Drowsiness	59 Participants	67 Participants	65 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Drowsiness	18 Participants	20 Participants	17 Participants
Number of Subjects With Solicited General Symptoms. G 3 Drowsiness	1 Participants	3 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. Rel Drowsiness	55 Participants	65 Participants	61 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Drowsiness	1 Participants	3 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. MA Drowsiness	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Irritability / Fussiness	86 Participants	94 Participants	76 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Irritability / Fussiness	26 Participants	35 Participants	23 Participants
Number of Subjects With Solicited General Symptoms. G 3 Irritability / Fussiness	3 Participants	4 Participants	4 Participants
Number of Subjects With Solicited General Symptoms. Rel Irritability / Fussiness	85 Participants	92 Participants	68 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Irritability / Fussiness	3 Participants	4 Participants	4 Participants
Number of Subjects With Solicited General Symptoms. MA Irritability / Fussiness	0 Participants	0 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Loss of appetite	47 Participants	47 Participants	46 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Loss of appetite	8 Participants	9 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. G 3 Loss of appetite	1 Participants	2 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. Rel Loss of appetite	44 Participants	44 Participants	41 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Loss of appetite	1 Participants	2 Participants	2 Participants
Number of Subjects With Solicited General Symptoms. MA Loss of appetite	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	4 Participants	10 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. ≥ G 2 Fever	1 Participants	1 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. G 3 Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. Rel Fever	2 Participants	10 Participants	9 Participants
Number of Subjects With Solicited General Symptoms. G3 Rel Fever	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms. MA Fever	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster vaccination.

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

Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)

Outcome measures

Measure	Infanrix Hexa Group n=167 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=158 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=161 Participants Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Number of Subjects With Specific AEs.	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster vaccination.

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

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Outcome measures

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

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-booster vaccination.

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

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

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

Adverse Events

Infanrix Hexa Group

Serious events: 8 serious events

Other events: 188 other events

Deaths: 0 deaths

Pediarix Group

Serious events: 1 serious events

Other events: 190 other events

Deaths: 0 deaths

Pentacel Group

Serious events: 8 serious events

Other events: 187 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infanrix Hexa Group n=195 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Blood and lymphatic system disorders Leukocytosis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Gastroenteritis viral	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Meningitis viral	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Parainfluenzae virus infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Pneumonia	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Near drowning	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Metabolism and nutrition disorders Dehydration	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Metabolism and nutrition disorders Hyponatraemia	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Febrile convulsion	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Lethargy	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Seizure	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Seizure like phenomena	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Psychiatric disorders Mental status changes	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Choking	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Petechiae	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).

Other adverse events

Measure	Infanrix Hexa Group n=195 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pediarix Group n=194 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh.	Pentacel Group n=196 participants at risk Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh.
Ear and labyrinth disorders Ear pain	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Ear and labyrinth disorders Ear disorder	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Ear infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Acute sinusitis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Adverse drug reaction	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Blood and lymphatic system disorders Anaemia	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Anal abscess	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Anal fistula	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Arthropod bite	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Arthropod sting	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Musculoskeletal and connective tissue disorders Asymmetric gluteal fold	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Reproductive system and breast disorders Balanoposthitis	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Investigations Body temperature increased	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Bronchiolitis	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Bronchitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Candida infection	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Candida nappy rash	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Investigations Cardiac murmur	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Cellulitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Ear and labyrinth disorders Cerumen impaction	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Eye disorders Chalazion	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Concussion	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Congenital skin dimples	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Conjunctivitis	5.1% 10/195 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.6% 9/194 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Conjunctivitis bacterial	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Conjunctivitis viral	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Constipation	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.6% 5/196 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Contusion	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Corneal abrasion	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Cough	8.7% 17/195 • Number of events 20 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.1% 8/194 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	3.6% 7/196 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Croup infectious	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Crying	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Cardiac disorders Cyanosis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Eye disorders Dacryostenosis acquired	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Dacryostenosis congenital	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Metabolism and nutrition disorders Decreased appetite	57.4% 112/195 • Number of events 201 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	64.9% 126/194 • Number of events 236 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	64.8% 127/196 • Number of events 235 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Dermatitis	2.1% 4/195 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Dermatitis atopic	2.6% 5/195 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.1% 8/194 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	3.6% 7/196 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Dermatitis contact	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Dermatitis diaper	2.1% 4/195 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.1% 4/194 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	5.1% 10/196 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Diarrhoea	3.1% 6/195 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	3.6% 7/194 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	6.6% 13/196 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Immune system disorders Drug hypersensitivity	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Dry skin	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Eczema	2.6% 5/195 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.6% 5/194 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.0% 4/196 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Eczema herpeticum	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Exanthema subitum	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Eye infection	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Fall	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Flatulence	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Folliculitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Immune system disorders Food allergy	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Foreign body	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Frequent bowel movements	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Fungal infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Fungal skin infection	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Gastric infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Gastroenteritis	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.1% 8/194 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Reproductive system and breast disorders Genital labial adhesions	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Hair growth abnormal	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Hand-foot-and-mouth disease	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Head injury	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Herpangina	0.51% 1/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Hordeolum	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Hydrocele	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Hyperreflexia	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Hypospadias	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Ill-defined disorder	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Impetigo	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Influenza	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Ingrowing nail	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Inguinal hernia	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site bruising	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.6% 5/196 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site erythema	57.4% 112/195 • Number of events 228 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	66.5% 129/194 • Number of events 299 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	59.2% 116/196 • Number of events 248 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site induration	1.5% 3/195 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site mass	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site nodule	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site pain	72.3% 141/195 • Number of events 322 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	83.5% 162/194 • Number of events 423 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	77.6% 152/196 • Number of events 361 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site pruritus	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site rash	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site scab	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site swelling	47.2% 92/195 • Number of events 166 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	53.1% 103/194 • Number of events 201 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	45.9% 90/196 • Number of events 180 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Injection site warmth	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Psychiatric disorders Irritability	85.6% 167/195 • Number of events 461 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	94.3% 183/194 • Number of events 544 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	91.8% 180/196 • Number of events 488 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Blood and lymphatic system disorders Lymphadenopathy	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Macrocephaly	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Immune system disorders Milk allergy	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Mouth injury	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	3.1% 6/194 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Nasal injury	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Nasopharyngitis	2.1% 4/195 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.0% 4/196 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Nausea	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Oedema peripheral	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Oral candidiasis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Otitis externa	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Otitis media	5.1% 10/195 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	5.7% 11/194 • Number of events 13 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	6.1% 12/196 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Otitis media acute	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Otitis media chronic	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Reproductive system and breast disorders Penile adhesion	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Reproductive system and breast disorders Penile erythema	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Peripheral swelling	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Pertussis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Pharyngitis	0.51% 1/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Phimosis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Congenital, familial and genetic disorders Plagiocephaly	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Pneumonia	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Poor quality sleep	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Musculoskeletal and connective tissue disorders Positional plagiocephaly	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Post inflammatory pigmentation change	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Pruritus	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Pyrexia	42.1% 82/195 • Number of events 133 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	43.8% 85/194 • Number of events 136 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	41.8% 82/196 • Number of events 130 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Rash	3.1% 6/195 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.1% 8/194 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	3.1% 6/196 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Respiratory syncytial virus infection	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Respiratory tract infection	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Rhinitis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.6% 5/195 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.1% 4/194 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.6% 5/196 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Roseola	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Psychiatric disorders Screaming	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Immune system disorders Seasonal allergy	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Seborrhoea	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Sinusitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Skin abrasion	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Skin candida	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Sneezing	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Somnolence	77.9% 152/195 • Number of events 355 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	89.2% 173/194 • Number of events 450 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	88.3% 173/196 • Number of events 411 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Speech disorder developmental	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Staphylococcal infection	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Stomatitis	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Swelling	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Teething	4.1% 8/195 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	5.2% 10/194 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	5.6% 11/196 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Nervous system disorders Tremor	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Ear and labyrinth disorders Tympanic membrane perforation	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Upper respiratory tract infection	16.4% 32/195 • Number of events 35 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	13.4% 26/194 • Number of events 31 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	16.3% 32/196 • Number of events 35 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Urinary tract infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Vaccination site bruising	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Vaccination site erythema	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.6% 5/194 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Vaccination site induration	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Vaccination site pain	1.0% 2/195 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
General disorders Vaccination site swelling	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.52% 1/194 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.0% 2/196 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Viraemia	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Viral infection	2.1% 4/195 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/194 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	4.1% 8/196 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Viral rash	1.5% 3/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	2.0% 4/196 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/195 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Vomiting	6.7% 13/195 • Number of events 13 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	5.2% 10/194 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	6.1% 12/196 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Gastrointestinal disorders Vomiting projectile	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/196 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Investigations Weight decreased	0.51% 1/195 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.51% 1/196 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).
Respiratory, thoracic and mediastinal disorders Wheezing	1.0% 2/195 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	0.00% 0/194 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).	1.5% 3/196 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Day 0-Day 3) follow-up period after each dose. Unsolicited AEs: during the 31-day (Day 0-Day 30) follow-up period after each dose. SAEs: during the entire study period (from Month 0 to Month 17).

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