CompletedInterventionalPhase 3Last updated Sep 11, 2018

Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.

Overview

ClinicalTrials.gov ID: NCT02584816
Lead Sponsor: Serum Institute of India Pvt. Ltd.INDUSTRY
Brief Summary: This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
Study Type: Interventional

Status

Overall Status: Completed
Start Date: Nov 2015
Primary Completion Date: Apr 2017Actual
Completion Date: Jun 2017Actual

Study Record Dates

First Submitted: Oct 6, 2015
First Submitted that Met QC Criteria: Oct 21, 2015
First Posted: Oct 23, 2015Estimated
Last Update Submitted that Met QC Criteria: Sep 7, 2018
Last Update Posted: Sep 11, 2018Actual
Last Verified: Sep 2018

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