A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
Phase 3
Completed
- Conditions
- Infections, Streptococcal
- Registration Number
- NCT00307554
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.
- Detailed Description
Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control group receiving Prevenar + DTPa combined vaccine
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
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 Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD Non-inferiority of 10-valent pneumococcal conjugate vaccine (pooled data of 3 10-Pn-PD-DiT vaccine groups) w.r.t. Prevenar: all anti-pneumococcal serotypes Ab concentrations>=0.20 µg/mL
- Secondary Outcome Measures
Name Time Method S+/seroprotection status to antigens in DTPa combo vaccine After each vaccination, occurrence of: solicited local, general symptoms within 4 days; After each vaccination Unsolicited adverse events within 31 days, SAEs (whole study period) 1m post dose3: For all vaccine pneumococcal serotypes: Opsono titres Antibody (Ab) concentrations >= 0.20 µg/mL Ab concentrations to protein D and seropositivity (S+) status
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇱Trzebnica, Poland