Sanofi and GlaxoSmithKline (GSK) have initiated the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The vaccine candidate – developed in partnership by Sanofi and GSK – uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US.
The first results are anticipated in early December 2020 to support the initiation of a Phase 3 trial beginning later that month.
If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021, the companies said.