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
Latest Information Update: 31 Mar 2025
At a glance
- Drugs MRNA 1283 (Primary) ; Elasomeran
- Indications COVID 2019 infections
- Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
- Acronyms NextCOVE
- Sponsors Moderna Therapeutics
- 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.