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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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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: 15 Nov 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

    • 08 Nov 2024 According to a Moderna Therapeutics media release, based on the data from this study, the company has received Health Canada approval for RSV vaccine for adults aged 60 years and older. Supply of mRESVIA is anticipated in Canada in early 2025. Moderna continues to file for mRESVIA marketing authorizations worldwide.
    • 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.

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