Clinical trial
Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in…
NCT00439660 · Bharat Biotech International Limited, Industry · Completed
Key facts
| NCT number | NCT00439660 |
|---|---|
| Title | Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old |
| Official title | Double-Blind Randomized Placebo-Controlled Dose Escalating Phase Ib/IIa Study to Evaluate the Safety and Immunogenicity of Live Attenuated Oral Rotavirus Vaccine 116E in Healthy Non-Malnourished Infants 8 to 20 Weeks of Age |
| Lead sponsor | Bharat Biotech International Limited, Industry |
| Collaborators | Ministry of Science and Technology, India Centers for Disease Control and Prevention U.S. Fed National Institutes of Health (NIH) NIH Stanford University Indian Council of Medical Research PATH |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Diarrhea |
| Intervention type | Biological |
| Interventions | Oral Rotavirus Vaccine 116E Live Attenuated |
| Enrollment | 540 |
| Start date | Dec 1, 2006 |
| Primary completion | Nov 1, 2008 |
| Completion | Nov 1, 2008 |
| First posted | Feb 26, 2007 |
| Last update posted | Feb 23, 2021 |
| 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: