A randomized open label multi-center study to compare immunogenicity and safety of BBIL's ROTAVAC to GSK's ROTARIX rotavirus vaccine when administered orally to infants aged 6-8 weeks
Latest Information Update: 03 Jul 2019
At a glance
- Drugs ORV 116E (Primary) ; RIX 4414
- Indications Rotavirus infections
- Focus Pharmacodynamics
- Sponsors Bharat Biotech
- 06 Jun 2019 Primary endpoint (The difference in immunogenicity (GMTs) achieved with ROTAVAC , when administered orally as 3-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age is not inferior at the predefined margin to that achieved with ROTARIX,when administered orally as 2-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age) has been met, according to the results published in the Vaccine.
- 06 Jun 2019 Results published in the Vaccine
- 25 Aug 2016 New trial record