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A pivotal phase 3 non-inferiority comparative study to evaluate the safety and immunogenicity of ARCT-154 as a booster for COVID-19

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Trial Profile

A pivotal phase 3 non-inferiority comparative study to evaluate the safety and immunogenicity of ARCT-154 as a booster for COVID-19

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs ARCT-154 (Primary) ; Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Arcturus Therapeutics

    • Most Recent Events

    • 14 Feb 2025 According to CSL media release, the European Commission has granted marketing authorization for KOSTAIVE for individuals 18 years and older, based positive clinical efficacy and tolerability data from integrated phase 1/2/3 study and Phase 3 COVID-19 booster trials.The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024.
    • 19 Nov 2024 Results published in the Meiji Seika Pharma Media Release.
    • 19 Nov 2024 According to a Meiji Seika Pharma media release, data from this trial were published in the peer-reviewed journal The Lancet Infectious Diseases.

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