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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00136604
• Collaborator: (none)
• Enrollment: 617
• Locations: 3
• Arms: 5
• Actual Duration (Months): 3
• Patients Per Site: 205.7
• Patients Per Site Per Month: 68.8

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.

Condition or Disease	Intervention/Treatment	Phase
Whole Cell Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Diphtheria; Tetanus; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin	Biological: Tritanrix-HepB/Hib-MenAC; Biological: Mencevax ACWY; Biological: Tritanrix-HepB/Hiberix; Biological: Meningitec	Phase 3

Detailed Description

This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.

Study Design

• Study Type: Interventional
• Actual Enrollment: 617 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Prevention
• Official Title: Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC
• Actual Study Start Date: Jan 22, 2006
• Actual Primary Completion Date: Apr 23, 2006
• Actual Study Completion Date: Apr 23, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACAC GROUP 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; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
Experimental: ACHibPS GROUP 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; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine; Biological: Tritanrix-HepB/Hiberix; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Experimental: HibACPS GROUP 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; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; Biological: Mencevax ACWY; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
Experimental: HibHibPS GROUP 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 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 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; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine; Biological: Tritanrix-HepB/Hiberix; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
Experimental: CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are 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.	Biological: Tritanrix-HepB/Hiberix; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Biological: Meningitec; Wyeth's MenC CRM197 conjugated vaccine, Meningitec

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value [One month Post-Booster vaccination at 15-24 months of age]

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

2. Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value [One Month Post-Booster vaccination at 15-24 months of age]

   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).

3. Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value [One Month Post-Booster vaccination at 15-24 months of age]

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

Secondary Outcome Measures

1. Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

2. Anti-PRP Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

3. Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

4. Anti-SBA-MenC Antibody Titers [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

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

   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).

6. Anti-rSBA-MenA Antibody Titers [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

7. Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

8. Anti-PSC Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

9. Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

10. Anti-PSA Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

11. Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values [One month after (POST) the Booster vaccination at 15-24 months of age]

    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.

12. Anti-D Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

13. Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

14. Anti-TT Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

15. Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value [One month Post-Booster vaccination]

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

16. Anti-BPT Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

17. Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

18. Anti-HBs Antibody Concentrations [Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age]

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

19. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 4-day (Day 0 to Day 3) post-vaccination period]

    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.

20. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 4-day (Days 0-3) post-vaccination period]

    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.

21. Number of Subjects With Any Unsolicited Adverse Events (AEs) [During the 31-day (Days 0-30) post-vaccination period]

    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.

22. Number of Subjects With Serious Adverse Events (SAEs) [Up to one month Post-Booster vaccination]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 427 Days to 730 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male or female between and including 15 and 24 months of age

• Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)

Exclusion criteria:

• Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).

• History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition.

• A family history of congenital or hereditary immunodeficiency.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bangkok		Thailand	10400
2	GSK Investigational Site	Khon Kaen		Thailand	40002
3	GSK Investigational Site	Songkla		Thailand	90110

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Primary Study

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00136604
• Other Study ID Numbers: 104727 (Booster - 15-24 mths); 104730
• First Posted: Aug 29, 2005
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Prophylaxis diphtheria; Hib & meningococcal serogroup A & C disease
• Additional relevant MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany

Study Results

Participant Flow

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Period Title: Overall Study
STARTED	249	123	79	41	125
COMPLETED	248	122	79	41	124
NOT COMPLETED	1	1	0	0	1

Baseline Characteristics

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP	Total
Arm/Group Description	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.	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	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	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.	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 of all reporting groups
Overall Participants	249	123	79	41	125	617
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	17.90 (0.52)	17.8 (0.59)	17.7 (0.59)	17.7 (0.67)	17.8 (0.55)	17.82 (0.56)
Sex: Female, Male (Count of Participants)
Female	132 53%	56 45.5%	38 48.1%	21 51.2%	55 44%	302 48.9%
Male	117 47%	67 54.5%	41 51.9%	20 48.8%	70 56%	315 51.1%
Race/Ethnicity, Customized (Count of Participants)
East - South East Asian	249 100%	123 100%	79 100%	41 100%	125 100%	617 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
Description	Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Time Frame	One month Post-Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	CC GROUP
Arm/Group Description	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.	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.
Measure Participants	247	122
Number [Percentage]	100	100

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACAC GROUP, CC GROUP
	Comments	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.
	Type of Statistical Test	Non-Inferiority
	Comments	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage of subjects
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -1.53 to 3.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
Description	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).
Time Frame	One Month Post-Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP
Arm/Group Description	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.
Measure Participants	224
rSBA-MenA (L11)	100
rSBA-MenA (L10)	100

3. Primary Outcome

Title	Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
Description	Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Time Frame	One Month Post-Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	ACHibPS GROUP
Arm/Group Description	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.	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
Measure Participants	247	122
Number [Percentage]	100	100

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACAC GROUP, CC GROUP
	Comments	Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in seroprotection rate
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -1.53 to 3.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	247	122	76	41	122
Anti-PRP ≥ 0.15 µg/mL (Pre-Booster)	100	99.2	100	100	99.2
Anti-PRP ≥ 0.15 µg/mL (Post-Booster)	100	100	100	100	100
Anti-PRP ≥ 1 µg/mL (Pre-Booster)	88.3	86.1	88.2	87.8	89.3
Anti-PRP ≥ 1 µg/mL (Post-Booster)	100	100	100	100	100

5. Secondary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	247	122	76	41	122
Anti-PRP (Pre-Booster)	4.572	4.371	3.728	4.498	4.775
Anti-PRP (Post-Booster)	85.798	168.232	56.772	129.222	115.384

6. Secondary Outcome

Title	Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
Description	Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	CC GROUP
Arm/Group Description	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.	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	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.
Measure Participants	247	76	122
Anti-SBA-MENC ≥ 1:8 (Pre-Booster)	95.1	10.7	90.8
Anti-SBA-MENC ≥ 1:8 (Post-Booster)	100	100	100
Anti-SBA-MENC ≥ 1:128 (Pre-Booster)	82.1	8.0	61.3
Anti-SBA-MENC ≥1:128 (Post-Booster)	100	100	100

7. Secondary Outcome

Title	Anti-SBA-MenC Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	CC GROUP
Arm/Group Description	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.	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	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.
Measure Participants	247	76	122
Anti-SBA-MenC (Pre-Booster)	295.2	6.3	143.8
Anti-SBA-MenC (Post-Booster)	4891.2	1868.4	8068.6

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	HibHibPS GROUP
Arm/Group Description	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.	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	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.
Measure Participants	226	74	38
rSBA-MenA (L11) ≥ 1:8 Pre-Booster	99.6	88.6	94.1
rSBA-MenA (L11) ≥ 1:8 Post-Booster	100	100	97.4
rSBA-MenA (L11) ≥ 1:128 Pre-Booster	96.9	85.7	94.1
rSBA-MenA (L11) ≥1:128 Post-Booster	100	100	97.4
rSBA-MenA (L10) ≥ 1:8 Pre-Booster	88.8	54.2	57.6
rSBA-MenA (L10) ≥ 1:8 Post-Booster	100	100	90.0
rSBA-MenA (L10) ≥ 1:128 Pre-Booster	66.1	42.4	42.4
rSBA-MenA (L10) ≥ 1:128 Post-Booster	100	100	70.0

9. Secondary Outcome

Title	Anti-rSBA-MenA Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	HibHibPS GROUP
Arm/Group Description	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.	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	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.
Measure Participants	246	76	122
rSBA-MenA (L11), Pre-Booster	626.2	327.2	468.3
rSBA-MenA (L11), Post-Booster	1488.8	3429.6	411.5
rSBA-MenA (L10), Pre-Booster	141.1	37.1	33.8
rSBA-MenA (L10), Post-Booster	1784.8	1663.7	172.5

10. Secondary Outcome

Title	Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
Description	Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	CC GROUP
Arm/Group Description	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.	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	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.
Measure Participants	247	76	122
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)	97.2	3.9	97.5
Anti-PSC ≥ 0.3 µg/mL (Post-Booster)	100	100	100
Anti-PSC ≥ 2 µg/mL (Pre-Booster)	33.6	1.3	30.3
Anti-PSC ≥ 2 µg/mL (Post-Booster)	99.2	100	100

11. Secondary Outcome

Title	Anti-PSC Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	CC GROUP
Arm/Group Description	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.	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	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.
Measure Participants	247	76	122
Anti-PSC (Pre-Booster)	1.37	0.16	1.41
Anti-PSC (Post-Booster)	11.71	25.96	31.42

12. Secondary Outcome

Title	Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
Description	Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	HibHibPS GROUP
Arm/Group Description	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.	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	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.
Measure Participants	246	76	41
Anti-PSA ≥ 0.3 µg/ml (Pre-Booster)	78.9	18.4	7.3
Anti-PSA ≥ 0.3 µg/ml (Post-Booster)	100	100	15.0
Anti-PSA ≥ 2 µg/ml (Pre-Booster)	12.6	2.6	2.4
Anti-PSA ≥ 2 µg/ml (Post-Booster)	97.6	100	0.0

13. Secondary Outcome

Title	Anti-PSA Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	HibACPS GROUP	HibHibPS GROUP
Arm/Group Description	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.	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	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.
Measure Participants	246	76	41
Anti-PSA (Pre-Booster)	0.64	0.20	0.17
Anti-PSA (Post-Booster)	20.31	14.20	0.19

14. Secondary Outcome

Title	Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
Description	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.
Time Frame	One month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	117
Number [Percentage]	99.2	100	100	100	100

15. Secondary Outcome

Title	Anti-D Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	117
Anti-D (Pre-Booster)	0.126	0.137	0.134	0.124	0.168
Anti-D (Post-Booster)	4.705	5.003	5.297	5.777	9.269

16. Secondary Outcome

Title	Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
Description	Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	117
Anti-TT (Pre-Booster)	99.2	99.2	97.4	97.6	96.6
Anti-TT (Post-Booster)	100	100	100	100	100

17. Secondary Outcome

Title	Anti-TT Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	117
Anti-TT (Pre-Booster)	0.709	0.648	0.617	0.537	0.566
Anti-TT (Post-Booster)	16.313	18.942	12.531	13.125	10.792

18. Secondary Outcome

Title	Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
Description	Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).
Time Frame	One month Post-Booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	114	111	69	38	110
Number [Percentage]	98.2	100	100	97.4	99.1

19. Secondary Outcome

Title	Anti-BPT Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	118	117	74	40	117
Anti-BPT (Pre-Booster)	11.7	10.5	10.6	10.5	11.1
Anti-BPT (Post-Booster)	122.1	115.9	129.1	112.6	102.5

20. Secondary Outcome

Title	Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
Description	Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	116
Anti-HBs (Pre-Booster)	82.6	90.8	94.7	90.2	81.6
Anti-HBs (Post-Booster)	95.8	97.5	98.7	100	96.6

21. Secondary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time Frame	Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	120	119	76	41	116
Anti-HBs (Pre-Booster)	54.8	91.2	95.0	84.4	65.6
Anti-HBs (Post-Booster)	3451.8	7801.4	6547.7	7265.8	3334.0

22. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	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.
Time Frame	During the 4-day (Day 0 to Day 3) post-vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	248	122	79	41	124
Any Pain	206 82.7%	90 73.2%	61 77.2%	31 75.6%	87 69.6%
Grade 3 Pain	55 22.1%	18 14.6%	15 19%	6 14.6%	22 17.6%
Any Redness	142 57%	68 55.3%	44 55.7%	19 46.3%	55 44%
Grade 3 Redness	5 2%	1 0.8%	0 0%	0 0%	5 4%
Any Swelling	114 45.8%	48 39%	38 48.1%	20 48.8%	51 40.8%
Grade 3 Swelling	3 1.2%	3 2.4%	2 2.5%	0 0%	4 3.2%

23. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	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.
Time Frame	During the 4-day (Days 0-3) post-vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	248	122	79	41	124
Any Drowsiness	159 63.9%	71 57.7%	46 58.2%	24 58.5%	58 46.4%
Grade 3 Drowsiness	1 0.4%	2 1.6%	1 1.3%	0 0%	4 3.2%
Related Drowsiness	159 63.9%	71 57.7%	46 58.2%	24 58.5%	58 46.4%
Any Irritability	198 79.5%	89 72.4%	58 73.4%	29 70.7%	79 63.2%
Grade 3 Irritability	14 5.6%	3 2.4%	4 5.1%	2 4.9%	8 6.4%
Related Irritability	198 79.5%	89 72.4%	58 73.4%	29 70.7%	79 63.2%
Any Loss of appetite	130 52.2%	54 43.9%	32 40.5%	19 46.3%	57 45.6%
Grade 3 Loss of appetite	6 2.4%	3 2.4%	0 0%	0 0%	2 1.6%
Related Loss of appetite	130 52.2%	54 43.9%	32 40.5%	19 46.3%	57 45.6%
Any Fever	133 53.4%	56 45.5%	43 54.4%	20 48.8%	55 44%
Grade 3 Fever	21 8.4%	6 4.9%	7 8.9%	4 9.8%	11 8.8%
Related Fever	133 53.4%	56 45.5%	43 54.4%	20 48.8%	55 44%

24. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	During the 31-day (Days 0-30) post-vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	249	123	79	41	125
Count of Participants [Participants]	7 2.8%	4 3.3%	0 0%	2 4.9%	8 6.4%

25. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	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.
Time Frame	Up to one month Post-Booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACAC GROUP	ACHibPS GROUP	HibACPS GROUP	HibHibPS GROUP	CC GROUP
Arm/Group Description	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.	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	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	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.	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.
Measure Participants	249	123	79	41	125
Count of Participants [Participants]	8 3.2%	0 0%	1 1.3%	1 2.4%	1 0.8%

Adverse Events

Time Frame	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).
Arm/Group Title	ACAC GROUP		ACHibPS GROUP		HibACPS GROUP		HibHibPS GROUP		CC GROUP
Arm/Group Description	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.		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		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		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.		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.
All Cause Mortality
	ACAC GROUP		ACHibPS GROUP		HibACPS GROUP		HibHibPS GROUP		CC GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/249 (0%)		0/123 (0%)		0/79 (0%)		0/41 (0%)		0/125 (0%)
Serious Adverse Events
	ACAC GROUP		ACHibPS GROUP		HibACPS GROUP		HibHibPS GROUP		CC GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/249 (3.2%)		0/123 (0%)		1/79 (1.3%)		1/41 (2.4%)		1/125 (0.8%)
Gastrointestinal disorders
Diarrhoea	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Infections and infestations
Bronchiolitis	0/249 (0%)	0	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	1/125 (0.8%)	1
Gastroenteritis	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Gastroenteritis viral	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Pharyngitis	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Urinary tract infection	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Nervous system disorders
Febrile convulsion	4/249 (1.6%)	5	0/123 (0%)	0	1/79 (1.3%)	1	1/41 (2.4%)	1	0/125 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	1/249 (0.4%)	1	0/123 (0%)	0	0/79 (0%)	0	0/41 (0%)	0	0/125 (0%)	0
Other (Not Including Serious) Adverse Events
	ACAC GROUP		ACHibPS GROUP		HibACPS GROUP		HibHibPS GROUP		CC GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	234/249 (94%)		115/123 (93.5%)		75/79 (94.9%)		38/41 (92.7%)		113/125 (90.4%)
General disorders
Pain	206/249 (82.7%)	206	90/123 (73.2%)	90	61/79 (77.2%)	61	31/41 (75.6%)	31	87/125 (69.6%)	87
Pyrexia	135/249 (54.2%)	135	57/123 (46.3%)	57	43/79 (54.4%)	44	20/41 (48.8%)	20	56/125 (44.8%)	57
Swelling	114/249 (45.8%)	114	48/123 (39%)	48	38/79 (48.1%)	38	20/41 (48.8%)	20	51/125 (40.8%)	51
Infections and infestations
Upper respiratory tract infection	11/249 (4.4%)	11	7/123 (5.7%)	7	2/79 (2.5%)	2	0/41 (0%)	0	7/125 (5.6%)	7
Metabolism and nutrition disorders
Decreased appetite	130/249 (52.2%)	130	54/123 (43.9%)	54	32/79 (40.5%)	32	19/41 (46.3%)	19	57/125 (45.6%)	57
Nervous system disorders
Somnolence	159/249 (63.9%)	159	71/123 (57.7%)	71	46/79 (58.2%)	46	24/41 (58.5%)	24	58/125 (46.4%)	58
Psychiatric disorders
Irritability	198/249 (79.5%)	198	89/123 (72.4%)	89	58/79 (73.4%)	58	29/41 (70.7%)	29	79/125 (63.2%)	79
Skin and subcutaneous tissue disorders
Erythema	142/249 (57%)	142	68/123 (55.3%)	68	44/79 (55.7%)	44	19/41 (46.3%)	19	55/125 (44%)	55

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.