Clinical trial
Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
NCT00757926 is registered in ClinicalTrials.gov with Shantha Biotechnics Limited as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
- Lead sponsor
- Shantha Biotechnics Limited
- Phase
- Phase 1/2
- Overall status
- Withdrawn
- Start date
- September 30, 2009
- Completion date
- September 30, 2010
- Enrollment
- 240 (estimated)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.