NCT01061658

Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shantha Biotechnics Limited · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine	Higher dosage of vaccine
BIOLOGICAL	Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine	Lower dosage of vaccine
OTHER	Placebo	Placebo

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-02-03
• Last updated: 2010-10-04

Locations

1 site across 1 country: India