To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus

PHASE3CompletedINTERVENTIONAL
Enrollment

1,975

Participants

Timeline

Start Date

March 20, 2015

Primary Completion Date

October 30, 2015

Study Completion Date

December 30, 2016

Conditions
Rotavirus Gastroenteritis
Interventions
BIOLOGICAL

ROTAVAC®

ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer

BIOLOGICAL

ROTAVAC 5C -F1

ROTAVAC 5C formulation BBIL-R2014-1

BIOLOGICAL

ROTAVAC 5C -F2

ROTAVAC 5C formulation BBIL-R2014-2

All Listed Sponsors
collaborator

Georgia Institute for Clinical Research, LLC

OTHER

lead

Bharat Biotech International Limited

INDUSTRY