Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)
Completed
- Conditions
- Vaccination against meningococcal diseaseInfections and InfestationsVaccination
- Registration Number
- ISRCTN35754083
- Lead Sponsor
- GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
Healthy infants between 6 - 8 weeks of age at first vaccination.
Exclusion Criteria
Any condition that may affect the health of the subject, or the interpretation of the results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Demonstrate immunogenicity of HibMenAMenC/DPTwHepB with respect to serum bacterial assay(SBA)-Men A and SBA-MenC<br>2. Demonstrate that HibMenAMenC/DPTwHepB is non-inferior to the control vaccine DPTwHepB/Hib with respect to immunogenicity of all common antigens (anti-PRP, anti-Diphtheria, anti-tetanus, anti-BP, anti-HBs)
- Secondary Outcome Measures
Name Time Method 1. Evaluate antibody persistence induced by the primary vaccination with HibMenAMenC/DPTwHepB versus DPTwHepB/Hib with respect to immunogenicity of all antigens administered at 12 months of age<br>2. Evaluate immune memory induced by primary vaccination with HibMenAMenC/DPTwHepB by administering 10 micrograms of each meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) using unprimed subjects of DPTwHepB/Hib as control<br>3. Assess immunogenecity and safety of the primary vaccination after each vaccine dose and overall in the two study groups<br>4. To assess the reactogenicity and safety of the 10 micrograms of meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) in subjects primed with either HibMenAMenC/DPTwHepB or DPTwHepB/Hib