Clinical trial
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy…
NCT00383903 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00383903 |
|---|---|
| Title | Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa |
| Official title | 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… |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Infections, Rotavirus |
| Intervention type | Biological |
| Interventions | HRV vaccine |
| Enrollment | 472 |
| Start date | Sep 1, 2003 |
| Primary completion | Sep 1, 2004 |
| Completion | Sep 1, 2004 |
| First posted | Oct 4, 2006 |
| Last update posted | Sep 15, 2016 |
| Countries | South Africa |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: