Trial Outcomes & Findings for Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine (NCT NCT01449812)

Results Overview

A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

831 participants

Primary outcome timeframe

Before the booster vaccination (At Day 0)

Results posted on

2018-06-06

Participant Flow

6 subjects did not receive vaccination.

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Infanrix+Hib/Poliorix 1 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Control Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Overall Study STARTED	272	273	280
Overall Study COMPLETED	270	273	279
Overall Study NOT COMPLETED	2	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Infanrix+Hib/Poliorix 1 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Control Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Overall Study Migrated/moved from study area	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Total n=825 Participants Total of all reporting groups
Age, Continuous	19.5 Months STANDARD_DEVIATION 0.93 • n=5 Participants	19.4 Months STANDARD_DEVIATION 0.91 • n=7 Participants	19.5 Months STANDARD_DEVIATION 0.97 • n=5 Participants	19.47 Months STANDARD_DEVIATION 0.94 • n=4 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	126 Participants n=7 Participants	120 Participants n=5 Participants	377 Participants n=4 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	147 Participants n=7 Participants	160 Participants n=5 Participants	448 Participants n=4 Participants
Race/Ethnicity, Customized Asian-Chinese heritage	272 Participants n=5 Participants	273 Participants n=7 Participants	280 Participants n=5 Participants	825 Participants n=4 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Control Group n=279 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids Anti-D	234 Participants	241 Participants	250 Participants
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids Anti-T	275 Participants	269 Participants	271 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=279 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-D and Anti-T Antibody Concentrations Anti-D	0.154 IU/mL Interval 0.142 to 0.166	0.175 IU/mL Interval 0.163 to 0.188	0.189 IU/mL Interval 0.176 to 0.202
Anti-D and Anti-T Antibody Concentrations Anti-T	0.38 IU/mL Interval 0.359 to 0.404	0.45 IU/mL Interval 0.423 to 0.478	0.509 IU/mL Interval 0.481 to 0.54

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)	241 Participants	226 Participants	234 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PRP Antibody Concentrations	2.413 µg/mL Interval 2.006 to 2.904	2.275 µg/mL Interval 1.856 to 2.788	2.674 µg/mL Interval 2.193 to 3.26

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 1	270 Participants	259 Participants	267 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 2	250 Participants	248 Participants	261 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 3	257 Participants	254 Participants	259 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 1	77.2 Titers Interval 67.0 to 89.0	72.3 Titers Interval 62.4 to 83.7	95.7 Titers Interval 82.5 to 111.0
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 2	42.6 Titers Interval 35.7 to 50.8	57.3 Titers Interval 47.0 to 70.0	63.6 Titers Interval 53.5 to 75.5
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-polio 3	60.6 Titers Interval 51.2 to 71.8	71.3 Titers Interval 60.1 to 84.7	79.9 Titers Interval 66.4 to 96.2

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT	260 Participants	260 Participants	263 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA	262 Participants	262 Participants	267 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN	267 Participants	260 Participants	265 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	10.4 EL.U/mL Interval 9.6 to 11.2	10.3 EL.U/mL Interval 9.6 to 11.1	12.2 EL.U/mL Interval 11.3 to 13.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	12.4 EL.U/mL Interval 11.5 to 13.4	12.8 EL.U/mL Interval 11.9 to 13.7	14.3 EL.U/mL Interval 13.4 to 15.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	9 EL.U/mL Interval 8.5 to 9.5	9.2 EL.U/mL Interval 8.8 to 9.7	9.7 EL.U/mL Interval 9.2 to 10.1

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids Anti-D	228 Participants	235 Participants	245 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids Anti-T	268 Participants	264 Participants	266 Participants

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids Anti-T	272 Participants	266 Participants	268 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids Anti-D	270 Participants	265 Participants	268 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-D and Anti-T Antibody Concentrations Anti-D	0.154 IU/mL Interval 0.142 to 0.166	0.174 IU/mL Interval 0.162 to 0.187	0.189 IU/mL Interval 0.176 to 0.202
Anti-D and Anti-T Antibody Concentrations Anti-T	0.38 IU/mL Interval 0.357 to 0.403	0.455 IU/mL Interval 0.429 to 0.483	0.511 IU/mL Interval 0.482 to 0.542

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Control Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-D and Anti-T Antibody Concentrations Anti-D	1.227 IU/mL Interval 1.134 to 1.326	1.341 IU/mL Interval 1.239 to 1.451	1.504 IU/mL Interval 1.377 to 1.643
Anti-D and Anti-T Antibody Concentrations Anti-T	4.371 IU/mL Interval 4.161 to 4.591	4.862 IU/mL Interval 4.614 to 5.124	4.927 IU/mL Interval 4.693 to 5.173

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

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

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)	234 Participants	221 Participants	229 Participants

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

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

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against PRP	271 Participants	264 Participants	268 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PRP Antibody Concentrations	2.407 µg/mL Interval 1.993 to 2.908	2.308 µg/mL Interval 1.878 to 2.836	2.743 µg/mL Interval 2.245 to 3.352

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PRP Antibody Concentrations	27.682 µg/mL Interval 24.251 to 31.598	35.178 µg/mL Interval 30.617 to 40.418	49.023 µg/mL Interval 43.649 to 55.058

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 Anti-Polio 1	263 Participants	253 Participants	262 Participants
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 Anti-Polio 2	244 Participants	243 Participants	256 Participants
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 Anti-Polio 3	250 Participants	249 Participants	254 Participants

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=265 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-Polio 1	273 Participants	265 Participants	268 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-Polio 2	273 Participants	265 Participants	268 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-Polio 3	273 Participants	265 Participants	268 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1	75.9 Titers Interval 65.7 to 87.6	72 Titers Interval 62.0 to 83.7	96.3 Titers Interval 82.8 to 112.0
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2	41.9 Titers Interval 35.0 to 50.0	56.5 Titers Interval 46.2 to 69.0	64.1 Titers Interval 53.8 to 76.4
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3	60.3 Titers Interval 50.8 to 71.6	72.6 Titers Interval 61.1 to 86.3	79.4 Titers Interval 65.8 to 95.8

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=265 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1	3386.8 Titers Interval 3078.0 to 3726.6	3512.2 Titers Interval 3159.7 to 3904.1	3410.9 Titers Interval 3081.7 to 3775.4
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2	1886.1 Titers Interval 1679.6 to 2117.9	1931.2 Titers Interval 1721.7 to 2166.2	2237.9 Titers Interval 2001.6 to 2502.1
Anti-polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3	5141.2 Titers Interval 4650.1 to 5684.2	5237.8 Titers Interval 4671.8 to 5872.3	5438.5 Titers Interval 4846.8 to 6102.4

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT	253 Participants	254 Participants	258 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	255 Participants	256 Participants	262 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	260 Participants	254 Participants	260 Participants

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT	273 Participants	266 Participants	268 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	273 Participants	266 Participants	268 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	273 Participants	266 Participants	268 Participants

PRIMARY outcome

Timeframe: Before the booster vaccination (At Day 0)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	10.3 EL.U/mL Interval 9.5 to 11.2	10.3 EL.U/mL Interval 9.5 to 11.1	12.2 EL.U/mL Interval 11.3 to 13.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	12.3 EL.U/mL Interval 11.4 to 13.3	12.7 EL.U/mL Interval 11.8 to 13.6	14.3 EL.U/mL Interval 13.4 to 15.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	9 EL.U/mL Interval 8.5 to 9.5	9.2 EL.U/mL Interval 8.7 to 9.6	9.7 EL.U/mL Interval 9.2 to 10.2

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions Anti-PT	126.8 EL.U/mL Interval 120.4 to 133.5	138.5 EL.U/mL Interval 132.0 to 145.3	146.2 EL.U/mL Interval 139.7 to 153.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions Anti-FHA	120.8 EL.U/mL Interval 115.3 to 126.6	124.6 EL.U/mL Interval 119.2 to 130.2	124 EL.U/mL Interval 119.2 to 129.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions Anti-PRN	57.2 EL.U/mL Interval 55.3 to 59.1	57.3 EL.U/mL Interval 55.6 to 59.1	59.9 EL.U/mL Interval 58.1 to 61.8

PRIMARY outcome

Timeframe: One month after the booster vaccination (At Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.

Outcome measures

Outcome measures
Measure	Control Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=266 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=268 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT	272 Participants	266 Participants	268 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	272 Participants	266 Participants	268 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	244 Participants	239 Participants	230 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.

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

Outcome measures

Outcome measures
Measure	Control Group n=279 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=270 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Subjects With Any Solicited Local Symptoms Any Pain	76 Participants	73 Participants	74 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	19 Participants	19 Participants	15 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	14 Participants	16 Participants	10 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.

Outcome measures

Outcome measures
Measure	Control Group n=279 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=270 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	38 Participants	38 Participants	50 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability	72 Participants	78 Participants	81 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	69 Participants	67 Participants	73 Participants
Number of Subjects With Any Solicited General Symptoms Any Fever	91 Participants	102 Participants	105 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.

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

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	21 Participants	16 Participants	13 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 up to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.

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

Outcome measures

Outcome measures
Measure	Control Group n=280 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 1 Group n=272 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 Participants Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	1 Participants	0 Participants

Adverse Events

Infanrix+Hib/Poliorix 1 Group

Serious events: 1 serious events

Other events: 157 other events

Deaths: 0 deaths

Infanrix+Hib/Poliorix 2 Group

Serious events: 0 serious events

Other events: 164 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infanrix+Hib/Poliorix 1 Group n=272 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Control Group n=280 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Nervous system disorders Febrile convulsion	0.37% 1/272 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	0.00% 0/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	0.00% 0/280 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
Infections and infestations Bronchopneumonia	0.37% 1/272 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	0.00% 0/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	0.00% 0/280 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).

Other adverse events

Other adverse events
Measure	Infanrix+Hib/Poliorix 1 Group n=272 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Infanrix+Hib/Poliorix 2 Group n=273 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.	Control Group n=280 participants at risk Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
General disorders Pain	27.0% 73/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	27.1% 74/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	27.2% 76/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Redness	7.0% 19/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	5.5% 15/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	5.7% 16/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Swelling	5.9% 16/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	3.7% 10/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	5.0% 14/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Drowsiness	14.1% 38/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	18.3% 50/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	13.6% 38/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Irritability	28.9% 78/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	29.7% 81/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	25.8% 72/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Loss of appetite	24.8% 67/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	26.7% 73/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	24.7% 69/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).
General disorders Fever	37.8% 102/270 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	38.5% 105/273 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).	32.6% 91/279 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 1).

Additional Information

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