Sanofi, GSK Initiate Phase 3 Clinical Efficacy Study Of COVID-19 Vaccine CandidateMay 27, 2021
GlaxoSmithKline PLC (GSK.L,GSK) and French drug maker Sanofi (SNY) announced Thursday that they have 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 companies expects that the vaccine could be approved in the fourth quarter of fiscal 2021, pending positive Phase 3 outcomes and regulatory reviews. Manufacturing will begin in the coming weeks to enable rapid access to the vaccine should it be approved.
The global randomized, double-blind, placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America.
In the trial, the primary endpoint is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints are the prevention of severe COVID-19 disease and prevention of asymptomatic infection.
The Phase 3 study follows the interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to100% seroconversion rates.
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.
The design of the Phase 3 study, which is being conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.
Further, the companies are planning to begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the initial vaccine platform received.
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