Sanofi, GSK get nod for Phase 3 efficacy trial of their Covid -19 vaccine candidate in India
The Hindu
In this partnership Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.
Sanofi and GSK said they have received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the U.S., Asia, Africa, and Latin America. As part of the study design, all participants, including the control group, will be offered the study vaccine as soon as it is determined to be safe and effective, Sanofi said.
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