Clinical trial
Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After…
NCT00169455 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00169455 |
|---|---|
| Title | Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants |
| Official title | A Phase IIIb, Partially Blind, Randomized, Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human… |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Rotavirus Gastroenteritis |
| Intervention type | Biological |
| Interventions | Live attenuated human rotavirus vaccine |
| Enrollment | 450 |
| Start date | Mar 1, 2005 |
| Primary completion | Dec 1, 2005 |
| Completion | Dec 1, 2005 |
| First posted | Sep 15, 2005 |
| Last update posted | Jan 16, 2017 |
| Countries | Thailand |
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: