Kolkata (West Bengal) [India], December 2 (ANI): West Bengal Governor Jagdeep Dhankhar inaugurated the phase III regulatory trial of Bharat Biotech's coronavirus vaccine candidate Covaxin in Kolkata on Wednesday.
"Inaugurated Phase III regulatory trial of COVAXIN at today at 11 am at ICMR (Indian Council of Medical Research) NICED (National Institute of Cholera and Enteric Diseases) II building at Kolkata," tweeted Dhankhar.
Bharat Biotech announced the commencement of Phase III trials of COVAXIN on November 17.
The Phase III trials will involve 26,000 volunteers across India and will be conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
This is India's first phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India. The trial has been registered at www.ctri.nic.in (CTRI/2020/11/028976) and approved by the Drugs Controller General of India.
Trial volunteers will receive two intramuscular injections about 28 days apart.
Participants will be randomly assigned to receive COVAXIN™ or placebo. The trial is double-blinded, such that the investigators, the participants, and the company will not be aware of who is assigned to which group. (ANI)