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A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E

NCT01305109 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6800

Last updated 2012-06-12

No results posted yet for this study

Summary

The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10\^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.

Conditions

  • Viral Gastroenteritis Due to Rotavirus

Interventions

BIOLOGICAL

ORV 116E

Oral Rotavirus Vaccine 116E (ORV 116E), 10\^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5mL at 4 week intervals

BIOLOGICAL

Placebo

3 doses of 0.5 mL at 4 week intervals

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • PATH

    collaborator OTHER

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Temsunaro R Chandola, MD, MSc · Centre for Health Research and Development, Society for Applied Studies

  • Gagandeep Kang, MDFRCPathPhD · Christian Medical College, Vellore, India

  • Ashish Bavdekar, MD,DCH,DNB · Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre,Vadu Rural Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2014-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT01305109 on ClinicalTrials.gov