A Phase IIb, double-blind, randomised, placebo-controlled parallel group study of the efficacy, safety and immunogenicity of oral RV3-BB Rotavirus Vaccine, administered as a neonatal schedule with birth (age 0-5 days) dose, 8-10 and 14-16 week doses or an infant schedule of 8-10 ,14-16 and 18-20 week doses.
Phase of Trial: Phase II
Latest Information Update: 22 Feb 2018
At a glance
- Drugs Rotavirus vaccine (Primary)
- Indications Rotavirus infections
- Focus Therapeutic Use
- Sponsors Biofarma
- 22 Feb 2018 Primary endpoint (Episodes of severe rotavirus gastroenteritis) has been met as per the results published in the New England Journal of Medicine.
- 22 Feb 2018 Results published in the New England Journal of Medicine
- 05 Sep 2016 Status changed from recruiting to completed.