Sanofi and GSK have received the drug regulator's nod to conduct the phase 3 clinical trial of their COVID-19 vaccine in India. The study will assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein vaccine candidate.

"India is participating in Sanofi Pasteur's pivotal phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," said Annapurna Das, Country Head, Sanofi Pasteur India.

The global, randomised, double-blind phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the United States, Asia, Africa and Latin America, news agency PTI quoted Sanofi as saying in a statement.

Sanofi and GSK have received the drug regulator's nod to conduct the phase 3 clinical trial of their COVID-19 vaccine in India. The study will assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein vaccine candidate.

"India is participating in Sanofi Pasteur's pivotal phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country," said Annapurna Das, Country Head, Sanofi Pasteur India.

The global, randomised, double-blind phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the United States, Asia, Africa and Latin America, news agency PTI quoted Sanofi as saying in a statement.