Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

Summary

A 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 would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.

Timeline

Start

2009-09

Primary completion

2010-08

Completion

2010-09

Outcome

Outcome not reported

Stopped: “Replaced with an alternate study”

Drugs

Indications