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A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

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Trial Profile

A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs MRNA-1010 (Primary) ; GSK 2321138A
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms IGNITE P303
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 05 Jan 2026 According to a Moderna media release, based on the P304 and P303 studies, the company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia for its seasonal influenza vaccine, mRNA-1010, for adults aged 50 years and older.
  • 22 Jul 2024 Status changed from active, no longer recruiting to completed.
  • 24 Feb 2024 According to a Moderna Therapeutics media release, Company is in ongoing discussions with regulators and intends to file in 2024.

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