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Ann: COVID19 Vaccine Feasibility Assessment, page-921

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    https://pharmaregnews.com/2021/04/22/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/

    Valneva SE, announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    The Phase 3 trial “Cov-Compare”, (VLA2001-301), will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial.

    Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).
 
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