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Clinical trial

Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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

NCT01061658 is registered in ClinicalTrials.gov with Shantha Biotechnics Limited as lead sponsor.

NCT NCT01061658
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Registry record

As filed in ClinicalTrials.gov.

Title
Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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
Lead sponsor
Shantha Biotechnics Limited
Phase
Phase 1/2
Overall status
Unknown status
Start date
July 31, 2010
Completion date
December 31, 2010
Enrollment
90 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

rotavirus gastroenteritis