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A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom

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Trial Profile

A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2023

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At a glance

  • Drugs Influenza vaccine (Optaflu) (Primary) ; Influenza virus vaccine (Primary) ; NVX CoV 2373 (Primary) ; Matrix M
  • Indications COVID-19 respiratory infection
  • Focus Registrational; Therapeutic Use
  • Sponsors Novavax
  • Most Recent Events

    • 18 Oct 2023 According to a Novavax media release, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid for individuals aged 12 and older for active immunization to help prevent COVID-19.
    • 14 Mar 2023 Status changed from active, no longer recruiting to completed.
    • 10 Oct 2022 protocol was amended on 25 February 2021 to include a blinded crossover phase in which subsequent doses of study vaccine were administered from 29 March to 14 June 2021, so all participants could receive active vaccine during the study as per results published in the Clinical Infectious Diseases.
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