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Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
DTPw-HBV/Hib-MenAC conjugate vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

6 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV). Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.

Sites / Locations

Outcomes

Primary Outcome Measures

One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration.

Secondary Outcome Measures

Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis)
One month after the third dose, antibody concentrations or titres against all vaccine antigens
Reactogenicity & safety: after each dose: solicited (d 0-7, local & general) & unsolicited (d 0-30) symptoms
Over the full course of the study: serious adverse events (SAEs)

Full Information

First Posted
February 14, 2006
Last Updated
December 7, 2006
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291967
Brief Title
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
Official Title
Evaluate the Feasibility of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6, 10 & 14 Weeks of Age
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.
Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) GSK Biologicals' Tritanrix™-HepB + GSK Biologicals' Hiberix™ GSK Biologicals' Tritanrix™-HepB mixed with GSK Biologicals' Hiberix™ + Wyeth Lederle's Meningitec™

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib Diseases, Neisseria Meningitidis Serogroups A & C Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
525 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
DTPw-HBV/Hib-MenAC conjugate vaccine
Primary Outcome Measure Information:
Title
One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration.
Secondary Outcome Measure Information:
Title
Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis)
Title
One month after the third dose, antibody concentrations or titres against all vaccine antigens
Title
Reactogenicity & safety: after each dose: solicited (d 0-7, local & general) & unsolicited (d 0-30) symptoms
Title
Over the full course of the study: serious adverse events (SAEs)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV). Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
City
Manila
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

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