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A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

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Trial Profile

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs MRNA 1083 (Primary) ; Elasomeran; Influenza virus vaccine
  • Indications COVID 2019 infections; Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 01 May 2025 According to a Moderna Therapeutics Media Release, Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.
  • 14 Feb 2025 According to a Moderna Therapeutics Media Release, Company has filed with the FDA for regulatory approval of mRNA-1083, which may require vaccine efficacy data from Moderna's ongoing Phase 3 seasonal flu vaccine study.
  • 12 Sep 2024 According to a Moderna Therapeutics Media Release, Company expects to file for approval in 2024 and intends to use a Priority Review Voucher.

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