Trial Profile

A Phase III, Randomized, Double blind, Placebo Controlled Trial to Evaluate the protective efficacy of three doses of Oral Rotavirus Vaccine (ORV) 116E, against severe Rotavirus gastroenteritis in infants.

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

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At a glance

Drugs ORV 116E (Primary) ; Diphtheria tetanus and pertussis vaccine; Hepatitis B vaccine; Measles vaccines; Poliovirus vaccine live oral; Tuberculosis vaccine
Indications Rotavirus infections
Focus Registrational; Therapeutic Use
Sponsors Bharat Biotech; PATH

12 Mar 2015 Based on data from this trial, the rotavirus vaccine ORV 116E [ROTAVAC] has been approved and launched in India, according to a Bharat Biotech media release.
12 Mar 2014 Results published in the Lancet online
14 May 2013 Results published in a Bharat Biotech media release and presented at the International Symposium on Rotavirus Vaccines for India.

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