Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vac... | NCT00136604

ID	Type	Description	Link
104730

Label	Type	Description	Intervention Names
ACAC GROUP	Experimental	Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are 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.	Biological: Tritanrix-HepB/Hib-MenAC
ACHibPS GROUP	Experimental	Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are 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 are 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	Biological: Mencevax ACWY Biological: Tritanrix-HepB/Hiberix
HibACPS GROUP	Experimental	Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are 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 are 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	Biological: Tritanrix-HepB/Hib-MenAC Biological: Mencevax ACWY
HibHibPS GROUP

Name	Type	Description	Arm Group Labels	Other Names
Tritanrix-HepB/Hib-MenAC	Biological	Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine

Measure	Description	Time Frame
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value	Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.	One month Post-Booster vaccination at 15-24 months of age
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value	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).	One Month Post-Booster vaccination at 15-24 months of age
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value	Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).	One Month Post-Booster vaccination at 15-24 months of age

Measure	Description	Time Frame
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values	Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Anti-PRP Antibody Concentrations

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bangkok		10400	Thailand
GSK Investigational Site

Label	URL
Primary Study	View source

ID	Type	URL	Comment
104727 (Booster - 15-24 mths)	Individual Participant Data Set	View IPD

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value

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

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000247 OG001122

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Denominators

Categories

Title	Measurements
	OG000100 OG001100

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.					Difference in percentage of subjects	0.00			2-Sided	95	-1.53	3.05					Non-Inferiority	Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.

Primary

Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value

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).

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value

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

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values

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

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-PRP Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

μg/mL

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values

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

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-SBA-MenC Antibody Titers

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

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

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

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).

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-rSBA-MenA Antibody Titers

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

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values

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

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-PSC Antibody Concentrations

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

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.

Posted

Geometric Mean

95% Confidence Interval

µg/ml

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values

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

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-PSA Antibody Concentrations

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

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.

Posted

Geometric Mean

95% Confidence Interval

µg/ml

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values

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.

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.

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-D Antibody Concentrations

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

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

Posted

Geometric Mean

95% Confidence Interval

IU/mL

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values

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

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-TT Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

IU/mL

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value

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

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

Posted

Number

Percentage

One month Post-Booster vaccination

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-BPT Antibody Concentrations

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

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

Posted

Geometric Mean

95% Confidence Interval

EL.U/ml

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value

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

Posted

Number

Percentage

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Anti-HBs Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

mIU/ml

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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.

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

Posted

Count of Participants

Participants

Up to one month Post-Booster vaccination

ID	Title	Description
OG000	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.
OG001	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

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	249	8	249	234	249
EG001	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	123	0	123	115	123
EG002	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	79	1	79	75	79
EG003	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.	41	1	41	38	41
EG004	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.	125	1	125	113	125

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile convulsion	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0005 events4 affected249 at risk EG0010 events0 affected123 at risk EG0021 events1 affected79 at risk EG0031 events1 affected41 at risk EG0040 events0 affected125 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected249 at risk EG0010 events0 affected123 at risk EG0020 events0 affected79 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Decreased appetite	Metabolism and nutrition disorders	MedDRA 9.1	Systematic Assessment	EG000130 events130 affected249 at risk EG00154 events54 affected123 at risk EG00232 events32 affected79 at risk EG00319 events19 affected41 at risk EG00457 events57 affected125 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 9.1	Systematic Assessment	EG000142 events142 affected249 at risk EG00168 events68 affected123 at risk EG00244 events44 affected79 at risk EG003
Irritability	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG000198 events198 affected249 at risk EG00189 events89 affected123 at risk EG00258 events58 affected79 at risk EG003
Pain	General disorders	MedDRA 9.1	Systematic Assessment	EG000206 events206 affected249 at risk EG00190 events90 affected123 at risk EG00261 events61 affected79 at risk EG003
Pyrexia	General disorders	MedDRA 9.1	Systematic Assessment	EG000135 events135 affected249 at risk EG00157 events57 affected123 at risk EG00244 events43 affected79 at risk EG003
Somnolence	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG000159 events159 affected249 at risk EG00171 events71 affected123 at risk EG00246 events46 affected79 at risk EG003
Swelling	General disorders	MedDRA 9.1	Systematic Assessment	EG000114 events114 affected249 at risk EG00148 events48 affected123 at risk EG00238 events38 affected79 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG00011 events11 affected249 at risk EG0017 events7 affected123 at risk EG0022 events2 affected79 at risk EG003

ID	Term
D006192	Haemophilus Infections
D006509	Hepatitis B
D004165	Diphtheria
D013742	Tetanus

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D003015	Clostridium Infections

ID	Title	Description
BG000	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.
BG001	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
BG002	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
BG003	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.
BG004	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.
BG005	Total	Total of all reporting groups