Trials / Completed
CompletedNCT00362648
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 7,504 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 4 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent | 2.0 mL oral dose of RotaTeq™. 14 week treatment period |
| BIOLOGICAL | Comparator: Placebo | Arm 2: Placebo. 14 week treatment period |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2006-08-10
- Last updated
- 2017-04-13
- Results posted
- 2010-05-13
Source: ClinicalTrials.gov record NCT00362648. Inclusion in this directory is not an endorsement.