Trials / Completed
CompletedNCT00241644
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,089 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 5 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system \[Ruuska, 1990\]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5. The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is \>0%. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study will have three groups: Rotarix 3-Dose Group, Rotarix 2-Dose Group and Placebo Group. Three-dose immunisation will be administered in healthy infants at approximately 6, 10, and 14 weeks of age. Routine EPI vaccinations will be administered concomitantly with the study vaccines. This study will also evaluate immunogenicity and safety relative to the placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rotarix™ | Two or Three doses, oral administration |
| BIOLOGICAL | Placebo | One or three doses, oral administration. |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2005-10-19
- Last updated
- 2016-12-09
- Results posted
- 2009-08-04
Locations
13 sites across 2 countries: Malawi, South Africa
Source: ClinicalTrials.gov record NCT00241644. Inclusion in this directory is not an endorsement.