Bharat Biotech has announced commencement of phase III clinical trial trials of COVAXIN yesterday. The phase III clinical trial trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. It is the most important clinical test conducted for a COVID-19 vaccine in India. This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and therefore the largest phase III clinical trial
efficacy trial ever conducted in India. The trial has been registered
at www.ctri.nic.in and approved by the Drugs Controller General of
India.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants are going to be randomly assigned to receive COVAXIN or placebo. The trial is double blinded, such the investigators, the participants and therefore the company won't remember of who is assigned to which group.
COVAXIN
has been evaluated in 1000 subjects in Phase I and Phase II clinical
trials, with promising safety and immunogencity data. Volunteers who
wish to participate during this trial should be adults over 18 years aged .
COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed together
with the Indian Council of Medical Research - National Institute of
Virology. This indigenous, inactivated vaccine is developed and made in Bharat Biotech's BSL-3 bio-containment facility.
COVAXIN may be a highly purified and inactivated vaccine, manufactured during a vero cell manufacturing platform with a superb safety diary of quite 300 million doses supplied
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