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A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age

Trial Profile

A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jul 2025

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At a glance

  • Drugs MRNA-1403 (Primary)
  • Indications Norovirus infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms NOVA-301
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 29 Jun 2025 Status changed from recruiting to active, no longer recruiting.
  • 13 Jan 2025 According to a Moderna media release, The Company anticipates efficacy data from the study in 2025 if sufficient cases are accrued in the first season; otherwise, the study will continue to a second season.
  • 07 Nov 2024 According to a Moderna media release, company initiated dosing in two pivotal Phase 3 trials to assess efficacy of investigational mRNA vaccines against norovirus and influenza.

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