The randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sitesthe Centre for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore. The Clinical Operations Management Unit headed by Dr Nita Bhandari at SAS oversaw the day-to-day coordination and logistical complexities of this multi-site study and played a pivotal role in the conduct of this trial. The Principal Investigators were Dr Temsunaro Rongsen-Chandola at SAS, Dr Ashish Bavdekar at KEM, and Dr Gagandeep Kang at CMC.
The Data Safety Monitoring Board (DSMB), an independent group of experts established to protect the participating infants' rights and needs during the Phase III trial, determined that the trial met the highest standards for ethics and patient care and complied with international standards for good clinical practices.
Bharat Biotech previously announced a price of US$ 1.00/dose (or approximately INR 54/dose) for ROTAVAC and will soon file for registration of the vaccine in India. If licensed by the Drugs Controller General of India (DCGI), the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market.
"With its low price and strong efficacy, ROTAVAC has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India," said Dr M.K. Bhan, Advisor to the Indian Academy of Pediatrics and former DBT Secretary.
The vaccine efficacy compares favourably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and
|Contact: Allison Clifford|