Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
- Conditions
- Haemophilus Influenzae Type bDiphtheriaTetanusHepatitis BWhole Cell Pertussis
- Registration Number
- NCT00317161
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.
- Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals' Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects).
- Secondary Outcome Measures
Name Time Method Solicited events (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study). Pre-dose 1, antibody levels to Men(A&C) & PRP; & in some subjects anti-BPT antibody levels Seropositivity/seroprotection/vaccine response & antibody levels
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇭Songkla, Thailand
GSK Investigational Site🇹🇭Songkla, Thailand