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A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age

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Trial Profile

A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2025

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At a glance

  • Drugs Elasomeran/davesomeran (Primary) ; Influenza vaccine quadrivalent Seqirus (Primary) ; MRNA-1345 (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms RSVictory
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 01 Apr 2025 Results assessing safety and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine or SARS-CoV-2 mRNA vaccine published in The Lancet Infectious Diseases
  • 04 Dec 2024 Status changed from active, no longer recruiting to completed.
  • 25 Apr 2024 According to a Moderna media release, data from this trial will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona, Spain, from April 27-30, 2024.

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