Trial Outcomes & Findings for A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia (NCT NCT02858440)

NCT ID: NCT02858440

Last Updated: 2019-09-24

Results Overview

A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 235 participants
• Primary outcome timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
• Results posted on: 2019-09-24

Participant Flow

Participant milestones

Measure	DTPa-IPV/Hib Group All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Overall Study STARTED	235
Overall Study COMPLETED	223
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	DTPa-IPV/Hib Group All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	2
Overall Study Consent withdrawal	3
Overall Study Migrated/moved from study area	4

Baseline Characteristics

A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia

Baseline characteristics by cohort

Measure	DTPa-IPV/Hib Group n=235 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Age, Continuous	14.1 Weeks STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	235 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination Anti-D antibody ≥ 0.1 IU/mL	176 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination Anti-T antibody ≥ 0.1 IU/mL	176 Participants

PRIMARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.

Outcome measures

Measure	DTPa-IPV/Hib Group n=151 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 1 antibody ≥ 8 ED50	151 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 2 antibody ≥ 8 ED50	151 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 3 antibody ≥ 8 ED50	150 Participants

PRIMARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Measure	DTPa-IPV/Hib Group n=182 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination	179 Participants

PRIMARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination Anti-FHA antibody ≥ 2.046 IU/mL	175 Participants
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination Anti-PRN antibody ≥ 2.187 IU/mL	175 Participants
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination Anti-PT antibody ≥ 2.693 IU/mL	174 Participants

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination anti-D antibody	188 Participants
Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination anti-T antibody	188 Participants

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination anti-Polio 1 antibody	176 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination anti-Polio 2 antibody	169 Participants
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination anti-Polio 3 antibody	167 Participants

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination	188 Participants

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-PT antibody	188 Participants
Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-FHA antibody	188 Participants
Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-PRN antibody	187 Participants

SECONDARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination Anti-D antibody	3.24 IU/mL Interval 2.84 to 3.68
Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination Anti-T antibody	3.14 IU/mL Interval 2.81 to 3.51

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination anti-D antibody	12.11 IU/mL Interval 10.82 to 13.56
Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination anti-T antibody	8.18 IU/mL Interval 7.35 to 9.11

SECONDARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

Outcome measures

Measure	DTPa-IPV/Hib Group n=151 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 1 antibody	613.9 Titers Interval 505.5 to 745.5
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 2 antibody	591.6 Titers Interval 487.3 to 718.3
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination Anti-Polio 3 antibody	827.4 Titers Interval 674.7 to 1014.6

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination anti-Polio 1 antibody	2185.4 Titers Interval 1901.1 to 2512.3
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination anti-Polio 2 antibody	2944.1 Titers Interval 2601.3 to 3332.2
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination anti-Polio 3 antibody	3684.6 Titers Interval 3225.3 to 4209.3

SECONDARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=182 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentration for Anti-PRP, Post Primary Vaccination	2.97 µg/mL Interval 2.48 to 3.54

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentration for Anti-PRP, Post Booster Vaccination	28.72 µg/mL Interval 24.7 to 33.4

SECONDARY outcome

Timeframe: At Month 4 (i.e. one month after 3rd dose of primary vaccination)

Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.

The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=176 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination Anti-FHA antibody	120.2 IU/mL Interval 107.0 to 135.1
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination Anti-PRN antibody	166.1 IU/mL Interval 146.8 to 187.8
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination Anti-PT antibody	65.0 IU/mL Interval 57.7 to 73.2

SECONDARY outcome

Timeframe: At Month 16 (i.e. one month after booster vaccination)

Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.

The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.

Outcome measures

Measure	DTPa-IPV/Hib Group n=188 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-FHA antibody	268.4 IU/mL Interval 242.4 to 297.2
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-PRN antibody	563.4 IU/mL Interval 495.6 to 640.5
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination anti-PT antibody	107.9 IU/mL Interval 96.5 to 120.7

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

Population: Total vaccinated cohort (TVC) for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

Outcome measures

Measure	DTPa-IPV/Hib Group n=232 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Pain, Dose 1	58 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Redness, Dose 1	83 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Swelling, Dose 1	45 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Pain, Dose 2	47 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Redness, Dose 2	89 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Swelling, Dose 2	58 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Pain, Dose 3	50 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Redness, Dose 3	96 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination Any Swelling, Dose 3	63 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.

Outcome measures

Measure	DTPa-IPV/Hib Group n=225 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Any Solicited Local AEs Following Booster Vaccination Any Pain	71 Participants
Number of Subjects With Any Solicited Local AEs Following Booster Vaccination Any Redness	101 Participants
Number of Subjects With Any Solicited Local AEs Following Booster Vaccination Any Swelling	73 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.

Outcome measures

Measure	DTPa-IPV/Hib Group n=232 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Drowsiness, Dose 1	82 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Irritability / Fussiness, Dose 1	100 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Loss Of Appetite, Dose 1	33 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Temperature/(Axillary) (°C), Dose 1	14 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Drowsiness, Dose 2	69 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Irritability / Fussiness, Dose 2	104 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Loss Of Appetite, Dose 2	34 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Temperature/(Axillary) (°C), Dose 2	32 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Drowsiness, Dose 3	65 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Irritability / Fussiness, Dose 3	106 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Loss Of Appetite, Dose 3	43 Participants
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination Any Temperature/(Axillary) (°C), Dose 3	28 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)

Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.

Outcome measures

Measure	DTPa-IPV/Hib Group n=225 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Any Solicited General AEs Following Booster Vaccination Any Drowsiness	54 Participants
Number of Subjects With Any Solicited General AEs Following Booster Vaccination Any Irritability / Fussiness	88 Participants
Number of Subjects With Any Solicited General AEs Following Booster Vaccination Any Loss Of Appetite	40 Participants
Number of Subjects With Any Solicited General AEs Following Booster Vaccination Any Temperature/(Axillary) (°C)	26 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)

Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.

An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.

Outcome measures

Measure	DTPa-IPV/Hib Group n=235 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination	48 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)

Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.

An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.

Outcome measures

Measure	DTPa-IPV/Hib Group n=225 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Unsolicited AEs Following Booster Vaccination	13 Participants

SECONDARY outcome

Timeframe: During the entire study period (i.e. from Day 0 until Month 16)

Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented, and TVC for analysis of safety of the booster epoch: all subjects with the booster vaccine dose administration documented.

The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.

Outcome measures

Measure	DTPa-IPV/Hib Group n=235 Participants All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Number of Subjects With Serious Adverse Events (SAEs)	3 Participants

Adverse Events

DTPa-IPV/Hib Group

Serious events: 3 serious events

Other events: 201 other events

Deaths: 0 deaths

Serious adverse events

Measure	DTPa-IPV/Hib Group n=235 participants at risk All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Gastrointestinal disorders Anal fistula	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Proctitis	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Congenital, familial and genetic disorders Heart disease congenital	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Gastric infection	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Vascular disorders Circulatory collapse	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.

Other adverse events

Measure	DTPa-IPV/Hib Group n=235 participants at risk All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side.
Infections and infestations Bronchitis	1.3% 3/235 • Number of events 3 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Cardiac disorders Cardiovascular disorder	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Constipation	0.43% 1/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Respiratory, thoracic and mediastinal disorders Cough	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Metabolism and nutrition disorders Decreased appetite	39.6% 93/235 • Number of events 150 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.43% 1/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Dystonia	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Ear infection	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Flatulence	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Psychiatric disorders Agitation	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Blood and lymphatic system disorders Anaemia	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Autonomic nervous system imbalance	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Immune system disorders Food allergy	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Hydrocephalus	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Immune system disorders Hypersensitivity	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Idiopathic intracranial hypertension	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Infantile colic	0.43% 1/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
General disorders Injection site erythema	59.6% 140/235 • Number of events 369 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
General disorders Injection site pain	43.8% 103/235 • Number of events 226 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
General disorders Injection site swelling	43.4% 102/235 • Number of events 239 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Psychiatric disorders Nightmare	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Motor dysfunction	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Nasopharyngitis	1.3% 3/235 • Number of events 3 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Pharyngitis	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Poor quality sleep	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
General disorders Pyrexia	28.5% 67/235 • Number of events 104 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Rash	2.1% 5/235 • Number of events 5 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Rash papular	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Regurgitation	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Respiratory tract infection	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Respiratory tract infection viral	2.1% 5/235 • Number of events 6 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Rhinitis	6.4% 15/235 • Number of events 18 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Somnolence	55.7% 131/235 • Number of events 270 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Tracheitis	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Tracheobronchitis	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Nervous system disorders Tremor	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Upper respiratory tract infection	1.7% 4/235 • Number of events 7 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Urinary tract infection	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Urticaria	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Varicella	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Viral infection	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Vomiting	0.85% 2/235 • Number of events 2 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Gastrointestinal disorders Diarrhoea	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
General disorders Irritability postvaccinal	66.8% 157/235 • Number of events 398 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Infections and infestations Enteritis infectious	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Metabolism and nutrition disorders Iron deficiency	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.7% 4/235 • Number of events 4 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.
Skin and subcutaneous tissue disorders Erythema	0.43% 1/235 • Number of events 1 • Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: lrs54533@gsk.com

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