1 min read.Updated: 21 Nov 2020, 05:36 AM ISTLeroy Leo
Bharat Biotech said people below 18 years or those who tested covid- positive will not be eligible for the clinical trial
Till the trial is on, the participants will not be allowed to take another company’s vaccine
Bharat Biotech International Ltd plans to enrol 1,000-2,000 participants each in metros like Delhi, Mumbai, Hyderabad and Kolkata for phase 3 trials of its covid-19 vaccine Covaxin that began earlier this week, the company said.
“Interested volunteers staying in the same city or near the clinical trial study site can meet/contact the principal investigator or co-investigator for participating in the clinical trial. The principal investigator will recruit the participant based on the protocol defined eligibility criteria," the company said in a statement to Mint.
Bharat Biotech said people below 18 years or those who tested positive for covid-19 earlier will not be eligible for the clinical trial, the largest efficacy trial ever in India.
After being screened for eligibility, trial participants will receive two intramuscular injections about 28 days apart. Participants will be randomly assigned equally to receive either two 6-microgram injections of Covaxin or two shots of a placebo.
The trial is double blinded, meaning the investigators, the participants and the company will not be aware of who is assigned to which group until the end of the trial.
“Whether a participant has received the vaccine or placebo, he/she will be made aware at the end of the study. The participants who received placebo will get the vaccine at the end of the study," the company said. The vaccine will be given only if efficacy trial results are successful.
Till the trial is on, the participants will not be allowed to take another company’s vaccine. However, if the efficacy data of Bharat Biotech is not strong enough to get authorization at the completion of the study, or the trial stops early based on interim results, the participant can take another vaccine as per the government’s standard care protocol, the company said.
Out of the 25 trial sites that will enrol 26,000 participants, the study has so far started at one—Hyderabad’s Nizam’s Institute of Medical Sciences.
As participation in the trial is voluntary and based on informed consent, participants will not be paid anything, other than travel fare. In the unfortunate event of any side-effect, the medical cost will be reimbursed, the company said. This is in line with ethical norms of an unbiased clinical trial.
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