Trials / Completed
CompletedNCT00169481
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 689 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 8 Weeks – 16 Weeks
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal (vaccine) |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2005-09-15
- Last updated
- 2017-01-10
Locations
56 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00169481. Inclusion in this directory is not an endorsement.