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A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

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Trial Profile

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

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

Latest Information Update: 11 Jul 2024

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At a glance

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

    • Most Recent Events

    • 31 May 2024 According to a Food and Drug Administration media release, based on data from this trial, the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation.
    • 10 May 2024 According to a Moderna Therapeutics media release, the FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345. Moderna remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) June 26-27, 2024, meeting.
    • 10 May 2024 According to a Moderna Therapeutics media release, company announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345 by the previously communicated Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.

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