NCT06592794

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

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 Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37,864 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Gastroenteritis
• Norovirus Acute Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1403	Intramuscular (IM) injection.
BIOLOGICAL	Placebo	0.9% sodium chloride solution by IM injection.

Timeline

• Start date: 2024-09-24
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2024-09-19
• Last updated: 2026-02-25

Locations

283 sites across 7 countries: United States, Australia, Canada, Japan, Panama, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study