The Drug Controller General of India (DCGI) has approved the global Phase 3 clinical trial of French pharma major Sanofi's Covid-19 vaccine candidate in India.
This would be the first global trial for a Covid-19 vaccine in India.
Sanofi, which is developing the vaccine with UK firm GlaxoSmithKline (GSK) said in a statement that it has received a green signal for the Phase 3 trial in India to "assess the safety, efficacy and immunogenicity’ of their Covid-19 vaccine candidate.
Prior to taking part in the trial, participants can get vaccinated with any approved Covid-19 if they wish to do so, the company's statement read.
The randomised, double-blind Phase 3 trial will be conducted globally and will include more than 35,000 volunteers, aged 18 and older, across sites in the US, Asia, Africa, and Latin America.
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