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A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years)

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Trial Profile

A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2023

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At a glance

  • Drugs Matrix-M1 Adjuvant (Primary) ; NVX CoV 2373 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms PREVENT-19
  • Sponsors Novavax

    • Most Recent Events

    • 19 Dec 2023 Status changed from active, no longer recruiting to completed.
    • 29 Nov 2023 Planned End Date changed from 31 Oct 2023 to 15 Dec 2023.
    • 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.
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