Clinical Trial

A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

Study acronym: Nova 301
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2024-09-09; most recent amendment 2026-05-08.
Status change: Recruiting → Active, Not Recruiting 2026-02-23
Status change: Active, Not Recruiting → Recruiting 2025-11-20
Status change: Recruiting → Active, Not Recruiting 2025-06-27
Status change: Not Yet Recruiting → Recruiting 2024-09-30
Trial Details
NCT Number NCT06592794
Lead Sponsor ModernaTX, Inc.
Conditions Acute Gastroenteritis, Norovirus Acute Gastroenteritis
Enrollment 37,864 participants
Start Date 2024-09-24
Primary Completion 2027-02-15 (estimated)
Study Completion 2027-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-13