May 3, 2021 -- Novavax has started a pediatric expansion of its phase III clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19.
The expansion will evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents ages 12-17 across 75 sites in the U.S., as part of its U.S./Mexico-based Prevent-19 trial.
Participants will randomly receive either the vaccine or placebo in two doses, administered 21 days apart. Two-thirds of participants will receive intramuscular injections for the vaccine while the other third will receive a placebo.
The company has planned for a blinded crossover to take place six months after an initial set of vaccinations to ensure that all participants receive an active vaccine. Participants will be monitored for safety for up to two years following a final dose.
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