Clinical trial
Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine…
NCT00280111 · Society for Applied Studies, Other · Completed
Key facts
| NCT number | NCT00280111 |
|---|---|
| Title | Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants |
| Official title | Reactogenicity and Immunogenicity of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Healthy Non-Malnourished Infants 8-12 Weeks of Age |
| Lead sponsor | Society for Applied Studies, Other |
| Collaborators | All India Institute of Medical Sciences National Institutes of Health (NIH) NIH Centers for Disease Control and Prevention U.S. Fed Stanford University Indian Institute of Science Children's Hospital… |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Rotavirus Infections |
| Intervention type | Biological, Drug |
| Interventions | 116E AGMK, I321, Placebo |
| Enrollment | 90 |
| Start date | Jan 1, 2005 |
| Primary completion | May 1, 2005 |
| Completion | May 1, 2005 |
| First posted | Jan 20, 2006 |
| Last update posted | Jul 2, 2008 |
| Countries | India |
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: