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Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

NCT01061658 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-10-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shantha Biotechnics Limited

    lead INDUSTRY

Principal Investigators

  • Raman Rao, MD · Shantha Biotechnics Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061658 on ClinicalTrials.gov