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
Price :
$35
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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.