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A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283.222 Administered as a Booster Dose Compared With mRNA-1273.222 in Participants Aged 12 Years and Older for the Prevention of COVID-19

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A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283.222 Administered as a Booster Dose Compared With mRNA-1273.222 in Participants Aged 12 Years and Older for the Prevention of COVID-19

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

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs MRNA 1283 (Primary) ; Elasomeran
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms NextCOVE
  • Sponsors Moderna Therapeutics

    • Most Recent Events

    • 14 Feb 2025 According to a Moderna Therapeutics media release, the Company has announced that FDA has accepted Moderna's Biologics License Application (BLA) for mRNA-1283 and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.
    • 11 Oct 2024 Planned End Date changed from 23 Aug 2024 to 18 Apr 2025.
    • 11 Oct 2024 Planned primary completion date changed from 23 Aug 2024 to 18 Apr 2025.

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