Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate will go under trials soon at Jeevan Rekha Hospital Belagavi.
The hospital was also part of the trials of Covaxin and ZyCov-D vaccines.
According to hospital director Amit Bhate, the Trials could commence in 10 days.
Dr Bhate said those aged above 18 and who are not vaccinated will be urged to volunteer for vaccine trials.
Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18.
The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence1 shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.