A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
Phase 2
Completed
- Conditions
- Streptococcal Infections
- Registration Number
- NCT00169481
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
- Detailed Description
Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 689
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination 1 Month after dose 3
- Secondary Outcome Measures
Name Time Method 1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa. 1 Month after dose 3
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Hamburg, Germany