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A Randomized, Observer-Blind, Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the SARS-CoV-2 Self- Amplifying RNA Vaccine ARCT-154 in Adults

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Trial Profile

A Randomized, Observer-Blind, Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the SARS-CoV-2 Self- Amplifying RNA Vaccine ARCT-154 in Adults

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs ARCT-154 (Primary) ; AZD 1222
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Vinbiocare Biotechnology

Most Recent Events

  • 15 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.
  • 20 May 2024 According to an Arcturus Therapeutics media release, Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154.
  • 20 May 2024 Results published in an Arcturus Therapeutics Media Release.

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