Trials / Completed
CompletedNCT00808444
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 466 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal conjugate vaccine GSK1024850A (different lots) | Intramuscular injection, 3 doses |
| BIOLOGICAL | Infanrix hexa | Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore |
| BIOLOGICAL | Infanrix-IPV/Hib | Intramuscular injection, only for Visit 2 in Singapore |
| BIOLOGICAL | Rotarix | Oral, 2 doses |
Timeline
- Start date
- 2009-01-05
- Primary completion
- 2009-11-02
- Completion
- 2009-11-02
- First posted
- 2008-12-15
- Last updated
- 2018-08-17
- Results posted
- 2010-11-19
Locations
5 sites across 2 countries: Malaysia, Singapore
Source: ClinicalTrials.gov record NCT00808444. Inclusion in this directory is not an endorsement.