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Latest on COVID-19 - Indias biggest vaccine trial starts!
Posted on: 18/Nov/2020 12:35:04 PM
As per its testing schedules on the raging coronavirus pandemic vaccine, Bharat Biotech has announced the commencement of Phase III trials of Covaxin.
These Phase III trials, conducted in partnership with ICMR, will involve 26,000 volunteers across India.
According to Bharat Biotech, it is the largest clinical trial conducted for a Covid-19 vaccine in India.
Bharath Biotech has announced: “This is India’s first phase three 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.clri.nic.in and approved by the Drugs Controller General of India."
As such, the trial volunteers will receive two intramuscular injections approximately 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.
Bharath Biotech furthered its announcement: "Covaxin has been evaluated in - 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age."
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