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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: 02 Mar 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

  • 10 Feb 2026 According to a Moderna media release, the company announced that mRNA-1010 has been accepted for review in the EU, Canada and Australia. Submissions in additional countries are planned for 2026. Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to those ongoing regulatory reviews.
  • 10 Feb 2026 According to a Moderna media release, the company announced the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has notified the Company that it will not initiate a review of the biologics license application (BLA) for its mRNA-1010, and has issued a Refusal-to-File (RTF) letter. Moderna has requested a Type A meeting with CBER to understand the basis for the RTF letter.
  • 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.

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