drugset / Trial / NCT01091298

A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

NCT01091298 ↗

Phase 1 Completed 20 enrolled Shantha Biotechnics Limited
RandomizedParallel-groupTriple-blindPrevention

Summary

This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.

Timeline

Start
2010-04
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV) Vaccine 0.5 ml Oral

Indications