Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Phase 2
Completed
- Conditions
- Hepatitis BTetanusHaemophilus Influenzae Type bDiphtheriaPoliomyelitisAcellular Pertussis
- Registration Number
- NCT00307567
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Booster and immune memory study
- Detailed Description
Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 689
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
- Secondary Outcome Measures
Name Time Method Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres* Ab concentrations to protein D & seropositivity (S+) status Occurrence of: solicited local*,general *symptoms within 4 d
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Berlin, Germany