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GSK: initiates phase I/II trial for Covid-19 vaccine

( - Sanofi and GSK announce the launch of a phase I/II clinical trial of their adjuvanted recombinant protein-based vaccine candidate, which is based on Sanofi's recombinant protein technology and the pandemic adjuvant developed by GSK.

This randomised double-blind, placebo-controlled trial is intended to assess its safety, tolerance and immunogenicity profiles. A total of 440 healthy adults will be included in this trial conducted in 11 study sites in the United States.

Both companies intend to obtain the first results in early December 2020, with a view to progressing to phase III in December this year. If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021.

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