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

NCT00136604 | Completed Phase 3 Results

• 2 other identifiers: 104727 (Booster - 15-24 mths)104730
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 3

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.

Conditions

Whole Cell Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Diphtheria; Tetanus; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin

Keywords

Prophylaxis diphtheria; Hib & meningococcal serogroup A & C disease

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

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

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

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

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

Secondary Outcomes (22)

• 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

• Anti-PRP Antibody Concentrations

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

• 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

• Anti-SBA-MenC Antibody Titers

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

• Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values

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

Study Arms (5)

ACAC GROUP

EXPERIMENTAL

Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age.

Biological: Tritanrix-HepB/Hib-MenAC

ACHibPS GROUP

EXPERIMENTAL

Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm

Biological: Mencevax ACWY; Biological: Tritanrix-HepB/Hiberix

HibACPS GROUP

EXPERIMENTAL

Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm

Biological: Tritanrix-HepB/Hib-MenAC; Biological: Mencevax ACWY

HibHibPS GROUP

EXPERIMENTAL

Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of 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; Biological: Tritanrix-HepB/Hiberix

CC GROUP

EXPERIMENTAL

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; Biological: Meningitec

Interventions

Tritanrix-HepB/Hib-MenAC BIOLOGICAL

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine

ACAC GROUP; HibACPS GROUP

Mencevax ACWY BIOLOGICAL

GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

ACHibPS GROUP; HibACPS GROUP; HibHibPS GROUP

Tritanrix-HepB/Hiberix BIOLOGICAL

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine

ACHibPS GROUP; CC GROUP; HibHibPS GROUP

Meningitec BIOLOGICAL

Wyeth's MenC CRM197 conjugated vaccine, Meningitec

CC GROUP

Eligibility Criteria

• Age: 427 Days - 730 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Songkhla, 90110, Thailand

Location

Related Links

• Primary Study

MeSH Terms

Conditions

Haemophilus Infections; Hepatitis B; Diphtheria; Tetanus

Interventions

PsACWY vaccine

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: January 22, 2006
• Primary Completion: April 23, 2006
• Study Completion: April 23, 2006
• Last Updated: February 20, 2020
• Results First Posted: September 17, 2018

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)