Trials / Completed
CompletedNCT00383903
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 472 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 5 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HRV vaccine | Two or three oral doses |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2004-09-01
- Completion
- 2004-09-01
- First posted
- 2006-10-04
- Last updated
- 2016-09-15
Locations
6 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT00383903. Inclusion in this directory is not an endorsement.