Clinical trial
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human…
NCT00420745 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00420745 |
|---|---|
| Title | To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants |
| Official title | Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Infections, Rotavirus |
| Intervention type | Biological |
| Interventions | Rotarix™, Placebo |
| Enrollment | 1,009 |
| Start date | Jan 25, 2007 |
| Primary completion | Mar 1, 2008 |
| Completion | Mar 25, 2008 |
| First posted | Jan 11, 2007 |
| Last update posted | Jun 8, 2018 |
| Countries | France, Poland, Portugal, Spain |
At a glance
- 10–99 Study sites
- Yes 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: