Trial Outcomes & Findings for Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m (NCT NCT00136604)

NCT ID: NCT00136604

Last Updated: 2020-02-20

Results Overview

Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 617 participants
• Primary outcome timeframe: One month Post-Booster vaccination at 15-24 months of age
• Results posted on: 2020-02-20

Participant Flow

Participant milestones

Measure	ACAC GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	ACHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Overall Study STARTED	249	123	79	41	125
Overall Study COMPLETED	248	122	79	41	124
Overall Study NOT COMPLETED	1	1	0	0	1

Reasons for withdrawal

Measure	ACAC GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	ACHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Overall Study Lost to Follow-up	1	0	0	0	1
Overall Study Migrated/moved from study area	0	1	0	0	0

Baseline Characteristics

Information about race distribution was not available in the report; it was obtained from the primary study.

Baseline characteristics by cohort

Measure	ACAC GROUP n=249 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	ACHibPS GROUP n=123 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibACPS GROUP n=79 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=125 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	Total n=617 Participants Total of all reporting groups
Age, Continuous	17.90 Months STANDARD_DEVIATION 0.52 • n=5 Participants	17.8 Months STANDARD_DEVIATION 0.59 • n=7 Participants	17.7 Months STANDARD_DEVIATION 0.59 • n=5 Participants	17.7 Months STANDARD_DEVIATION 0.67 • n=4 Participants	17.8 Months STANDARD_DEVIATION 0.55 • n=21 Participants	17.82 Months STANDARD_DEVIATION 0.56 • n=8 Participants
Sex: Female, Male Female	132 Participants n=5 Participants	56 Participants n=7 Participants	38 Participants n=5 Participants	21 Participants n=4 Participants	55 Participants n=21 Participants	302 Participants n=8 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	67 Participants n=7 Participants	41 Participants n=5 Participants	20 Participants n=4 Participants	70 Participants n=21 Participants	315 Participants n=8 Participants
Race/Ethnicity, Customized East - South East Asian	249 Participants n=5 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.	123 Participants n=7 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.	79 Participants n=5 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.	41 Participants n=4 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.	125 Participants n=21 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.	617 Participants n=8 Participants • Information about race distribution was not available in the report; it was obtained from the primary study.

PRIMARY outcome

Timeframe: One month Post-Booster vaccination at 15-24 months of age

Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group versus TRITANRIX-HEPB+Mencevax + Meningitec Group.

Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value	100 Percentage	100 Percentage	—	—	—

PRIMARY outcome

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group only.

Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).

Outcome measures

Measure	ACAC GROUP n=224 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value rSBA-MenA (L11)	100 Percentage	—	—	—	—
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value rSBA-MenA (L10)	100 Percentage	—	—	—	—

PRIMARY outcome

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT versus Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix groups.

Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value	100 Percentage	100 Percentage	—	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.

Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values Anti-PRP ≥ 0.15 µg/mL (Pre-Booster)	100 Percentage	99.2 Percentage	100 Percentage	100 Percentage	99.2 Percentage
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values Anti-PRP ≥ 0.15 µg/mL (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	100 Percentage	100 Percentage
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values Anti-PRP ≥ 1 µg/mL (Pre-Booster)	88.3 Percentage	86.1 Percentage	88.2 Percentage	87.8 Percentage	89.3 Percentage
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values Anti-PRP ≥ 1 µg/mL (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	100 Percentage	100 Percentage

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.

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

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-PRP Antibody Concentrations Anti-PRP (Pre-Booster)	4.572 μg/mL Interval 3.859 to 5.416	4.371 μg/mL Interval 3.411 to 5.602	3.728 μg/mL Interval 2.872 to 4.84	4.498 μg/mL Interval 3.144 to 6.436	4.775 μg/mL Interval 3.774 to 6.041
Anti-PRP Antibody Concentrations Anti-PRP (Post-Booster)	85.798 μg/mL Interval 75.274 to 97.793	168.232 μg/mL Interval 140.939 to 200.812	56.772 μg/mL Interval 44.788 to 71.962	129.222 μg/mL Interval 95.254 to 175.301	115.384 μg/mL Interval 95.55 to 139.336

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.

Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values Anti-SBA-MENC ≥ 1:8 (Pre-Booster)	95.1 Percentage	10.7 Percentage	90.8 Percentage	—	—
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values Anti-SBA-MENC ≥ 1:8 (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	—	—
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values Anti-SBA-MENC ≥ 1:128 (Pre-Booster)	82.1 Percentage	8.0 Percentage	61.3 Percentage	—	—
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values Anti-SBA-MENC ≥1:128 (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.

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

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-SBA-MenC Antibody Titers Anti-SBA-MenC (Pre-Booster)	295.2 Titers Interval 245.7 to 354.6	6.3 Titers Interval 4.6 to 8.7	143.8 Titers Interval 105.3 to 196.4	—	—
Anti-SBA-MenC Antibody Titers Anti-SBA-MenC (Post-Booster)	4891.2 Titers Interval 4466.0 to 5356.9	1868.4 Titers Interval 1495.0 to 2335.0	8068.6 Titers Interval 6717.7 to 9691.3	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.

Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).

Outcome measures

Measure	ACAC GROUP n=226 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=74 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=38 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L11) ≥ 1:8 Pre-Booster	99.6 Percentage	88.6 Percentage	94.1 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L11) ≥ 1:8 Post-Booster	100 Percentage	100 Percentage	97.4 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L11) ≥ 1:128 Pre-Booster	96.9 Percentage	85.7 Percentage	94.1 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L11) ≥1:128 Post-Booster	100 Percentage	100 Percentage	97.4 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L10) ≥ 1:8 Pre-Booster	88.8 Percentage	54.2 Percentage	57.6 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L10) ≥ 1:8 Post-Booster	100 Percentage	100 Percentage	90.0 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L10) ≥ 1:128 Pre-Booster	66.1 Percentage	42.4 Percentage	42.4 Percentage	—	—
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values rSBA-MenA (L10) ≥ 1:128 Post-Booster	100 Percentage	100 Percentage	70.0 Percentage	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.

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

Outcome measures

Measure	ACAC GROUP n=246 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-rSBA-MenA Antibody Titers rSBA-MenA (L11), Pre-Booster	626.2 Titers Interval 551.6 to 711.0	327.2 Titers Interval 215.4 to 497.0	468.3 Titers Interval 290.3 to 755.4	—	—
Anti-rSBA-MenA Antibody Titers rSBA-MenA (L11), Post-Booster	1488.8 Titers Interval 1318.7 to 1680.8	3429.6 Titers Interval 2939.5 to 4001.4	411.5 Titers Interval 297.0 to 570.0	—	—
Anti-rSBA-MenA Antibody Titers rSBA-MenA (L10), Pre-Booster	141.1 Titers Interval 115.1 to 172.9	37.1 Titers Interval 21.3 to 64.7	33.8 Titers Interval 17.1 to 67.0	—	—
Anti-rSBA-MenA Antibody Titers rSBA-MenA (L10), Post-Booster	1784.8 Titers Interval 1611.2 to 1977.1	1663.7 Titers Interval 1415.4 to 1955.6	172.5 Titers Interval 100.4 to 296.3	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.

Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)	97.2 Percentage	3.9 Percentage	97.5 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSC ≥ 0.3 µg/mL (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSC ≥ 2 µg/mL (Pre-Booster)	33.6 Percentage	1.3 Percentage	30.3 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSC ≥ 2 µg/mL (Post-Booster)	99.2 Percentage	100 Percentage	100 Percentage	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).

Outcome measures

Measure	ACAC GROUP n=247 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-PSC Antibody Concentrations Anti-PSC (Pre-Booster)	1.37 µg/ml Interval 1.24 to 1.53	0.16 µg/ml Interval 0.15 to 0.18	1.41 µg/ml Interval 1.23 to 1.62	—	—
Anti-PSC Antibody Concentrations Anti-PSC (Post-Booster)	11.71 µg/ml Interval 10.82 to 12.68	25.96 µg/ml Interval 22.73 to 29.65	31.42 µg/ml Interval 27.29 to 36.17	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.

Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).

Outcome measures

Measure	ACAC GROUP n=246 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSA ≥ 0.3 µg/ml (Pre-Booster)	78.9 Percentage	18.4 Percentage	7.3 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSA ≥ 0.3 µg/ml (Post-Booster)	100 Percentage	100 Percentage	15.0 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSA ≥ 2 µg/ml (Pre-Booster)	12.6 Percentage	2.6 Percentage	2.4 Percentage	—	—
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values Anti-PSA ≥ 2 µg/ml (Post-Booster)	97.6 Percentage	100 Percentage	0.0 Percentage	—	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().

Outcome measures

Measure	ACAC GROUP n=246 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-PSA Antibody Concentrations Anti-PSA (Pre-Booster)	0.64 µg/ml Interval 0.57 to 0.72	0.20 µg/ml Interval 0.17 to 0.23	0.17 µg/ml Interval 0.15 to 0.2	—	—
Anti-PSA Antibody Concentrations Anti-PSA (Post-Booster)	20.31 µg/ml Interval 17.92 to 23.01	14.20 µg/ml Interval 11.95 to 16.88	0.19 µg/ml Interval 0.16 to 0.23	—	—

SECONDARY outcome

Timeframe: One month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination.

Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA.

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values	99.2 Percentage	100 Percentage	100 Percentage	100 Percentage	100 Percentage

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-D Antibody Concentrations Anti-D (Pre-Booster)	0.126 IU/mL Interval 0.105 to 0.15	0.137 IU/mL Interval 0.116 to 0.162	0.134 IU/mL Interval 0.108 to 0.166	0.124 IU/mL Interval 0.091 to 0.169	0.168 IU/mL Interval 0.143 to 0.198
Anti-D Antibody Concentrations Anti-D (Post-Booster)	4.705 IU/mL Interval 3.714 to 5.962	5.003 IU/mL Interval 3.958 to 6.324	5.297 IU/mL Interval 3.968 to 7.07	5.777 IU/mL Interval 3.625 to 9.205	9.269 IU/mL Interval 7.812 to 10.997

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination

Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values Anti-TT (Pre-Booster)	99.2 Percentage	99.2 Percentage	97.4 Percentage	97.6 Percentage	96.6 Percentage
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values Anti-TT (Post-Booster)	100 Percentage	100 Percentage	100 Percentage	100 Percentage	100 Percentage

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-TT Antibody Concentrations Anti-TT (Pre-Booster)	0.709 IU/mL Interval 0.622 to 0.809	0.648 IU/mL Interval 0.57 to 0.737	0.617 IU/mL Interval 0.519 to 0.735	0.537 IU/mL Interval 0.427 to 0.675	0.566 IU/mL Interval 0.489 to 0.655
Anti-TT Antibody Concentrations Anti-TT (Post-Booster)	16.313 IU/mL Interval 15.089 to 17.636	18.942 IU/mL Interval 17.203 to 20.857	12.531 IU/mL Interval 10.902 to 14.405	13.125 IU/mL Interval 11.071 to 15.56	10.792 IU/mL Interval 9.618 to 12.108

SECONDARY outcome

Timeframe: One month Post-Booster vaccination

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	ACAC GROUP n=114 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=111 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=69 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=38 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=110 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value	98.2 Percentage	100 Percentage	100 Percentage	97.4 Percentage	99.1 Percentage

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).

Outcome measures

Measure	ACAC GROUP n=118 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=74 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=40 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=117 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-BPT Antibody Concentrations Anti-BPT (Pre-Booster)	11.7 EL.U/ml Interval 10.3 to 13.3	10.5 EL.U/ml Interval 9.5 to 11.7	10.6 EL.U/ml Interval 9.2 to 12.3	10.5 EL.U/ml Interval 8.8 to 12.6	11.1 EL.U/ml Interval 9.9 to 12.4
Anti-BPT Antibody Concentrations Anti-BPT (Post-Booster)	122.1 EL.U/ml Interval 109.8 to 135.8	115.9 EL.U/ml Interval 105.1 to 127.9	129.1 EL.U/ml Interval 114.0 to 146.2	112.6 EL.U/ml Interval 90.0 to 140.8	102.5 EL.U/ml Interval 92.4 to 113.7

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination

Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=116 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value Anti-HBs (Pre-Booster)	82.6 Percentage	90.8 Percentage	94.7 Percentage	90.2 Percentage	81.6 Percentage
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value Anti-HBs (Post-Booster)	95.8 Percentage	97.5 Percentage	98.7 Percentage	100 Percentage	96.6 Percentage

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination

Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	ACAC GROUP n=120 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=119 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=76 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=116 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Anti-HBs Antibody Concentrations Anti-HBs (Pre-Booster)	54.8 mIU/ml Interval 41.3 to 72.8	91.2 mIU/ml Interval 71.8 to 115.7	95.0 mIU/ml Interval 71.1 to 126.8	84.4 mIU/ml Interval 55.3 to 129.0	65.6 mIU/ml Interval 48.9 to 88.2
Anti-HBs Antibody Concentrations Anti-HBs (Post-Booster)	3451.8 mIU/ml Interval 2327.5 to 5119.4	7801.4 mIU/ml Interval 5724.2 to 10632.4	6547.7 mIU/ml Interval 4589.9 to 9340.5	7265.8 mIU/ml Interval 5028.1 to 10499.3	3334.0 mIU/ml Interval 2310.7 to 4810.5

SECONDARY outcome

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

Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Outcome measures

Measure	ACAC GROUP n=248 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=79 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=124 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	114 Participants	48 Participants	38 Participants	20 Participants	51 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	3 Participants	3 Participants	2 Participants	0 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	206 Participants	90 Participants	61 Participants	31 Participants	87 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	55 Participants	18 Participants	15 Participants	6 Participants	22 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	142 Participants	68 Participants	44 Participants	19 Participants	55 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	5 Participants	1 Participants	0 Participants	0 Participants	5 Participants

SECONDARY outcome

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

Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	ACAC GROUP n=248 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=122 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=79 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=124 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	21 Participants	6 Participants	7 Participants	4 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	159 Participants	71 Participants	46 Participants	24 Participants	58 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	1 Participants	2 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	159 Participants	71 Participants	46 Participants	24 Participants	58 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	198 Participants	89 Participants	58 Participants	29 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	14 Participants	3 Participants	4 Participants	2 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	198 Participants	89 Participants	58 Participants	29 Participants	79 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	130 Participants	54 Participants	32 Participants	19 Participants	57 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	6 Participants	3 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	130 Participants	54 Participants	32 Participants	19 Participants	57 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	133 Participants	56 Participants	43 Participants	20 Participants	55 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	133 Participants	56 Participants	43 Participants	20 Participants	55 Participants

SECONDARY outcome

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

Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.

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	ACAC GROUP n=249 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=123 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=79 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=125 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	7 Participants	4 Participants	0 Participants	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to one month Post-Booster vaccination

Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.

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

Outcome measures

Measure	ACAC GROUP n=249 Participants Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	CC GROUP n=123 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	HibACPS GROUP n=79 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=125 Participants Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Number of Subjects With Serious Adverse Events (SAEs)	8 Participants	0 Participants	1 Participants	1 Participants	1 Participants

Adverse Events

ACAC GROUP

Serious events: 8 serious events

Other events: 234 other events

Deaths: 0 deaths

ACHibPS GROUP

Serious events: 0 serious events

Other events: 115 other events

Deaths: 0 deaths

HibACPS GROUP

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

HibHibPS GROUP

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

CC GROUP

Serious events: 1 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACAC GROUP n=249 participants at risk Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	ACHibPS GROUP n=123 participants at risk Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibACPS GROUP n=79 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=125 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Nervous system disorders Febrile convulsion	1.6% 4/249 • Number of events 5 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	1.3% 1/79 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	2.4% 1/41 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Respiratory, thoracic and mediastinal disorders Asthma	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Bronchiolitis	0.00% 0/249 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.80% 1/125 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Gastrointestinal disorders Diarrhoea	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Gastroenteritis	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Gastroenteritis viral	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Pharyngitis	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Urinary tract infection	0.40% 1/249 • Number of events 1 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/123 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/125 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).

Other adverse events

Measure	ACAC GROUP n=249 participants at risk Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.	ACHibPS GROUP n=123 participants at risk Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibACPS GROUP n=79 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm	HibHibPS GROUP n=41 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.	CC GROUP n=125 participants at risk Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.
Metabolism and nutrition disorders Decreased appetite	52.2% 130/249 • Number of events 130 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	43.9% 54/123 • Number of events 54 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	40.5% 32/79 • Number of events 32 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	46.3% 19/41 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	45.6% 57/125 • Number of events 57 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Skin and subcutaneous tissue disorders Erythema	57.0% 142/249 • Number of events 142 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	55.3% 68/123 • Number of events 68 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	55.7% 44/79 • Number of events 44 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	46.3% 19/41 • Number of events 19 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	44.0% 55/125 • Number of events 55 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Psychiatric disorders Irritability	79.5% 198/249 • Number of events 198 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	72.4% 89/123 • Number of events 89 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	73.4% 58/79 • Number of events 58 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	70.7% 29/41 • Number of events 29 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	63.2% 79/125 • Number of events 79 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
General disorders Pain	82.7% 206/249 • Number of events 206 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	73.2% 90/123 • Number of events 90 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	77.2% 61/79 • Number of events 61 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	75.6% 31/41 • Number of events 31 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	69.6% 87/125 • Number of events 87 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
General disorders Pyrexia	54.2% 135/249 • Number of events 135 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	46.3% 57/123 • Number of events 57 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	54.4% 43/79 • Number of events 44 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	48.8% 20/41 • Number of events 20 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	44.8% 56/125 • Number of events 57 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Nervous system disorders Somnolence	63.9% 159/249 • Number of events 159 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	57.7% 71/123 • Number of events 71 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	58.2% 46/79 • Number of events 46 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	58.5% 24/41 • Number of events 24 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	46.4% 58/125 • Number of events 58 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
General disorders Swelling	45.8% 114/249 • Number of events 114 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	39.0% 48/123 • Number of events 48 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	48.1% 38/79 • Number of events 38 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	48.8% 20/41 • Number of events 20 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	40.8% 51/125 • Number of events 51 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).
Infections and infestations Upper respiratory tract infection	4.4% 11/249 • Number of events 11 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	5.7% 7/123 • Number of events 7 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	2.5% 2/79 • Number of events 2 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	0.00% 0/41 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).	5.6% 7/125 • Number of events 7 • Solicited local/general symptoms: during the 4-day (Days 0-3) post-booster vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-booster vaccination period. SAEs: up to one month post-booster dose (Visit 2).

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