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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

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
  • Most Recent Events

    • 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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