MedTrace Logo

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

NCT06592794 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37864

Last updated 2026-05-13

No results posted yet for this study

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

BIOLOGICAL

mRNA-1403

Intramuscular (IM) injection.

BIOLOGICAL

Placebo

0.9% sodium chloride solution by IM injection.

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2027-02-15
Completion
2027-02-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • Panama
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592794 on ClinicalTrials.gov