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A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M Adjuvant in People Living With HIV

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Trial Profile

A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M Adjuvant in People Living With HIV

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Mar 2023

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At a glance

  • Drugs Matrix M (Primary) ; NVX CoV 2373 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Novavax
  • Most Recent Events

    • 14 Mar 2023 Status changed from active, no longer recruiting to completed.
    • 18 Jan 2023 According to Novavax media release, the company announced that the partner SK biosciences has received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for NVX-CoV2373 for use as a booster for active immunization to prevent COVID-19 in adults aged 18 and older. The approval was based on the data from this study.
    • 25 May 2022 Planned End Date changed from 1 Jul 2022 to 1 Nov 2022.
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