Trials / Completed
CompletedNCT00092443
Dose Confirmation Efficacy Study (V260-007)
Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,312 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Detailed description
The duration of treatment is 10 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RotaTeq™, rotavirus vaccine, live, oral, pentavalent | Three doses of RotaTeq™ administered 28 to 70 days apart. |
| BIOLOGICAL | Comparator: Placebo matching RotaTeq™ | Placebo matching RotaTeq™ administered 28 to 70 days apart. |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2004-06-01
- Completion
- 2004-06-01
- First posted
- 2004-09-27
- Last updated
- 2015-09-14
- Results posted
- 2009-07-10
Source: ClinicalTrials.gov record NCT00092443. Inclusion in this directory is not an endorsement.