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A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

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Trial Profile

A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

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

Latest Information Update: 20 Jun 2025

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At a glance

  • Drugs MRNA-1345 (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 12 Jun 2025 According to a Moderna Therapeutics media release, the U.S. FDA has approved mRESVIA (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease, based on the data from this trial.
  • 01 May 2025 According to a Moderna Therapeutics media release, The FDA has assigned a PDUFA goal date of June 12, 2025.
  • 12 Sep 2024 Results presented in the Moderna Therapeutics Media Release

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