Trial Outcomes & Findings for Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants (NCT NCT00169442)

NCT ID: NCT00169442

Last Updated: 2018-06-06

Results Overview

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 745 participants
• Primary outcome timeframe: At Month 1, post-PRP challenge
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Overall Study STARTED	119	124	167	250	42	43
Overall Study COMPLETED	119	123	166	250	41	41
Overall Study NOT COMPLETED	0	1	1	0	1	2

Reasons for withdrawal

Measure	Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Overall Study Withdrawal by Subject	0	0	1	0	0	0
Overall Study Migrated/moved from study area	0	0	0	0	0	2
Overall Study Lost to follow-up (incompl. vaccination)	0	0	0	0	1	0
Overall Study Lost to follow-up (compl. vaccination)	0	1	0	0	0	0

Baseline Characteristics

Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

Baseline characteristics by cohort

Measure	Tritanrix-HepB/Hiberix Kft. Mix Group n=119 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=124 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=167 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB Kft.+Hiberix Group n=250 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Mix Group n=42 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	PRP Tritanrix-HepB Kft. Ref Group n=43 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Total n=745 Participants Total of all reporting groups
Age, Continuous	14.5 Months STANDARD_DEVIATION 1.44 • n=5 Participants	14.8 Months STANDARD_DEVIATION 2.07 • n=7 Participants	14.7 Months STANDARD_DEVIATION 1.89 • n=5 Participants	15.0 Months STANDARD_DEVIATION 2.04 • n=4 Participants	9.9 Months STANDARD_DEVIATION 0.68 • n=21 Participants	9.8 Months STANDARD_DEVIATION 0.61 • n=8 Participants	14.23 Months STANDARD_DEVIATION 1.75 • n=8 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	58 Participants n=7 Participants	90 Participants n=5 Participants	120 Participants n=4 Participants	21 Participants n=21 Participants	21 Participants n=8 Participants	359 Participants n=8 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	66 Participants n=7 Participants	77 Participants n=5 Participants	130 Participants n=4 Participants	21 Participants n=21 Participants	22 Participants n=8 Participants	386 Participants n=8 Participants
Race/Ethnicity, Customized East/South East Asian heritage	119 Participants n=5 Participants	124 Participants n=7 Participants	167 Participants n=5 Participants	250 Participants n=4 Participants	42 Participants n=21 Participants	43 Participants n=8 Participants	745 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Month 1, post-PRP challenge

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=39 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL Anti-PRP ≥ 0.15 μg/mL	—	39 Participants	41 Participants	—
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL Anti-PRP ≥ 1.0 μg/mL	—	37 Participants	39 Participants	—

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. Anti-PRP ≥ 0.15 μg/mL	74 Participants	77 Participants	71 Participants	88 Participants
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. Anti-PRP ≥ 1.0 μg/mL	74 Participants	76 Participants	70 Participants	88 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-D	73 Participants	74 Participants	68 Participants	88 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-T	74 Participants	77 Participants	71 Participants	88 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=73 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=70 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Seroprotection Rates for Anti-D Antibodies	100 Proportion Interval 95.1 to 100.0	100 Proportion Interval 95.3 to 100.0	100 Proportion Interval 94.9 to 100.0	100 Proportion Interval 95.9 to 100.0

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)	72 Participants	74 Participants	69 Participants	84 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=69 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=65 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=85 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)	69 Participants	74 Participants	65 Participants	85 Participants

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The booster response was defined as:

• an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or
• at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=68 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=65 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=84 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Booster Response to BPT Antigen	67 Participants	70 Participants	64 Participants	79 Participants

PRIMARY outcome

Timeframe: At Month 1, post-PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=39 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-PRP Antibody Concentrations	—	33.190 μg/mL Interval 18.546 to 59.397	22.727 μg/mL Interval 13.524 to 38.192	—

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-PRP Antibody Concentrations.	113.073 μg/mL Interval 82.28 to 155.389	56.670 μg/mL Interval 42.276 to 75.964	81.681 μg/mL Interval 58.576 to 113.9	58.669 μg/mL Interval 45.568 to 75.537

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-D and Anti-T Antibody Concentrations Anti-D	3.128 IU/mL Interval 2.344 to 4.174	3.087 IU/mL Interval 2.206 to 4.319	1.812 IU/mL Interval 1.354 to 2.425	3.452 IU/mL Interval 2.692 to 4.425
Anti-D and Anti-T Antibody Concentrations Anti-T	16.822 IU/mL Interval 13.682 to 20.682	13.371 IU/mL Interval 10.846 to 16.484	12.181 IU/mL Interval 9.994 to 14.848	12.838 IU/mL Interval 10.548 to 15.626

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-HBs Antibody Concentrations	2465.1 mIU/mL Interval 1572.6 to 3864.2	2400.0 mIU/mL Interval 1399.5 to 4115.8	1628.3 mIU/mL Interval 1041.4 to 2546.0	2467.9 mIU/mL Interval 1554.2 to 3918.9

PRIMARY outcome

Timeframe: At Month 1, post-booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=69 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=65 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=85 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-BPT Antibody Concentrations	93.5 EL.U/mL Interval 82.4 to 106.0	91.3 EL.U/mL Interval 82.1 to 101.4	118.8 EL.U/mL Interval 105.0 to 134.4	97.6 EL.U/mL Interval 89.0 to 107.1

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=38 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL Anti-PRP ≥ 0.15 μg/mL	—	37 Participants	41 Participants	—
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL Anti-PRP ≥ 1.0 μg/mL	—	32 Participants	34 Participants	—

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. Anti-PRP ≥ 0.15 μg/mL	72 Participants	74 Participants	69 Participants	84 Participants
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. Anti-PRP ≥ 1.0 μg/mL	49 Participants	53 Participants	62 Participants	66 Participants

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-T	69 Participants	72 Participants	67 Participants	86 Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value Anti-D	46 Participants	45 Participants	24 Participants	58 Participants

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Seroprotection Rates for Anti-D Antibodies	85.1 Proportion Interval 75.0 to 92.3	85.7 Proportion Interval 75.9 to 92.6	71.6 Proportion Interval 61.1 to 82.1	95.5 Proportion Interval 88.9 to 98.8

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value	56 Participants	56 Participants	44 Participants	69 Participants

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=73 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=75 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value	27 Participants	23 Participants	21 Participants	33 Participants

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=38 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti- PRP Antibody Concentrations	—	4.683 μg/mL Interval 2.602 to 8.428	4.507 μg/mL Interval 2.914 to 6.971	—

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=71 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti- PRP Antibody Concentrations.	2.904 μg/mL Interval 1.905 to 4.426	2.703 μg/mL Interval 1.771 to 4.125	5.312 μg/mL Interval 3.496 to 8.07	2.837 μg/mL Interval 1.953 to 4.121

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-D and Anti-T Antibody Concentrations. Anti-D	0.145 IU/mL Interval 0.116 to 0.181	0.117 IU/mL Interval 0.097 to 0.141	0.077 IU/mL Interval 0.066 to 0.09	0.162 IU/mL Interval 0.127 to 0.206
Anti-D and Anti-T Antibody Concentrations. Anti-T	0.446 IU/mL Interval 0.353 to 0.564	0.397 IU/mL Interval 0.321 to 0.491	0.512 IU/mL Interval 0.4 to 0.656	0.588 IU/mL Interval 0.464 to 0.745

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=74 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=77 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=89 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-HBs Antibody Concentrations.	43.6 mIU/mL Interval 29.8 to 63.7	43.6 mIU/mL Interval 29.4 to 64.8	26.1 mIU/mL Interval 18.0 to 38.0	70.5 mIU/mL Interval 46.9 to 105.8

SECONDARY outcome

Timeframe: At Month 0, prior to the PRP challenge

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group n=73 Participants Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=75 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=72 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=88 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Anti-BPT Antibody Concentrations.	11.9 EL.U/mL Interval 10.3 to 13.8	10.6 EL.U/mL Interval 9.4 to 12.1	10.7 EL.U/mL Interval 9.3 to 12.2	12.8 EL.U/mL Interval 10.9 to 15.1

SECONDARY outcome

Timeframe: During the 4-Day (Days 0-3) post-PRP challenge

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=42 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	—	13 Participants	12 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	—	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	—	11 Participants	15 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	—	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	—	7 Participants	11 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	—	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During the 4-Day (Days 0-3) post-PRP challenge

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=41 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=42 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	—	6 Participants	10 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	—	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	—	6 Participants	10 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Axillary)	—	4 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Axillary)	—	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever (Axillary)	—	4 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	—	11 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	—	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	—	11 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	—	5 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	—	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	—	5 Participants	7 Participants	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=82 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=409 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=250 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Pain	—	56 Participants	303 Participants	181 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	—	11 Participants	57 Participants	34 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Redness	—	46 Participants	255 Participants	152 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	—	7 Participants	58 Participants	50 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Swelling	—	44 Participants	250 Participants	140 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	—	16 Participants	84 Participants	65 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.

Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=82 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=409 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=250 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fever (Axillary)	—	59 Participants	270 Participants	168 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever (Axillary)	—	2 Participants	10 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fever (Axillary)	—	59 Participants	270 Participants	168 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Irritability	—	54 Participants	267 Participants	162 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability	—	2 Participants	17 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Irritability	—	54 Participants	266 Participants	161 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite	—	25 Participants	129 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite	—	1 Participants	6 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite	—	25 Participants	129 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness	—	34 Participants	174 Participants	105 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness	—	1 Participants	11 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness	—	33 Participants	174 Participants	104 Participants

SECONDARY outcome

Timeframe: During the 31-Day (Day 0-30) follow-up period

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

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

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=85 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=410 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=250 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Unsolicited Adverse Events (AEs)	—	22 Participants	27 Participants	14 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 9.5)

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

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

Outcome measures

Measure	Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Mix Group n=85 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	Tritanrix-HepB/Hiberix Kft. Ref Group n=410 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.	HB Tritanrix-HepB/Hiberix Kft. Mix Group n=250 Participants Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	—	1 Participants	0 Participants	0 Participants

Adverse Events

PRP Pooled Group

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Mix Pooled Group

Serious events: 0 serious events

Other events: 379 other events

Deaths: 0 deaths

Tritanrix-HepB Kft.+Hiberix Group

Serious events: 0 serious events

Other events: 231 other events

Deaths: 0 deaths

PRP TRITANRIX-HEPB KFT. MIX GROUP

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

PRP TRITANRIX-HEPB KFT. REF GROUP

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	PRP Pooled Group n=85 participants at risk PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.	Mix Pooled Group n=410 participants at risk Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.	Tritanrix-HepB Kft.+Hiberix Group n=250 participants at risk Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	PRP TRITANRIX-HEPB KFT. MIX GROUP n=42 participants at risk Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .	PRP TRITANRIX-HEPB KFT. REF GROUP n=43 participants at risk Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
Infections and infestations Bronchopneumonia	1.2% 1/85 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/410 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).

Other adverse events

Measure	PRP Pooled Group n=85 participants at risk PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.	Mix Pooled Group n=410 participants at risk Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.	Tritanrix-HepB Kft.+Hiberix Group n=250 participants at risk Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.	PRP TRITANRIX-HEPB KFT. MIX GROUP n=42 participants at risk Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .	PRP TRITANRIX-HEPB KFT. REF GROUP n=43 participants at risk Healthy male and female infants who were primed with Tritanrix -HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
Infections and infestations Upper respiratory tract infection	9.4% 8/85 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	2.0% 8/410 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	3.2% 8/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Pain (post-booster)	68.3% 56/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	74.1% 303/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	72.4% 181/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Redness (post-booster)	56.1% 46/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	62.3% 255/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	60.8% 152/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Swelling (post-booster)	53.7% 44/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	61.1% 250/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	56.0% 140/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Drowsiness (post-booster)	41.5% 34/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	42.5% 174/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	42.0% 105/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Fever (Axillary) (post-booster)	72.0% 59/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	66.0% 270/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	67.2% 168/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Iritability (post-booster)	65.9% 54/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	65.3% 267/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	64.8% 162/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Loss of appetite (post-booster)	30.5% 25/82 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	31.5% 129/409 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	31.6% 79/250 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	0.00% 0/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Pain (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	31.0% 13/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	27.9% 12/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Redness (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	26.2% 11/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	34.9% 15/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Swelling (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	16.7% 7/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	25.6% 11/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Drowsiness (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	14.3% 6/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	23.3% 10/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Fever (Axillary) (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	9.5% 4/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	16.3% 7/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Irritability (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	26.2% 11/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	18.6% 8/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).
General disorders Loss of appetite (post-PRP challenge)	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	— 0/0 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	11.9% 5/42 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).	16.3% 7/43 • Solicited local and general symptoms: during the 4-Day (Day 0-3) post-vaccination period (PRP challenge and booster); Unsolicited AEs: during the 31-Day (Day 0-30) post-booster; SAEs: during the entire study period (from Month 0 up to Month 9.5).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER