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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: 03 Mar 2026

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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

  • 25 Feb 2026 Status changed from recruiting to active, no longer recruiting.
  • 12 Jan 2026 According to a Moderna media release, company is enrolling patients in a second Northern Hemisphere season (2025-2026) for additional case accruals, which will inform the timing of the phase 3 readout. And, the company expects an interim analysis in 2026.
  • 26 Nov 2025 Planned number of patients changed from 25000 to 28000.

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