Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent liquid frozen vaccine containing live rotavirus 116E strain [G9 P(11)] prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL contains NLT 105.0 FFU of live Rotavirus 116E.
ROTAVAC® should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age and should not be administered to children older than 8 months of age. ROTAVAC® has a shelf life of 5 years when stored at -20°C till the expiry date and can be stored for up to six months between 5°C ±3°C.
Rotavirus 116E is isolated from asymptomatic neonates in 1986-88, at the All India Institute of Medical Sciences. ROTAVAC was developed as a Social Innovation Project under Public-Private Partnership involving highly regarded national and international organizations.
The multi-centre Phase III Efficacy and Safety clinical trial on ROTAVAC® was India’s 1st and largest efficacy clinical trial on vaccines. It was successfully completed in September 2013 after a 2-year follow up of the infants. Results of this study were published in Lancet, Vaccine.
The vaccine efficacy of ROTAVAC® for severe non-vaccine rotavirus gastroenteritis was 56.4% [95% Cl 36.6, 70.1] in the first year of life and the vaccine efficacy in the second year of the same study was 49% [95% Cl 17.5, 68.4].