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NCT06592794 · ClinicalTrials.gov registry record · Phase 3

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 study of Norovirus Acute Gastroenteritis and Acute Gastroenteritis, sponsored by ModernaTX.

Active
Registry status
Phase 3
Development phase
37,864
Enrollment target
20
Study locations

NCT06592794: Active Phase 3 study of Norovirus Acute Gastroenteritis and Acute Gastroenteritis, sponsored by ModernaTX.

NCT06592794 is a Phase 3 study of Norovirus Acute Gastroenteritis and Acute Gastroenteritis that is active but no longer recruiting, run by ModernaTX. The registered enrollment target is 37,864 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (4817% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06592794, a Phase 3 study of Norovirus Acute Gastroenteritis and Acute Gastroenteritis, is active but no longer recruiting, sponsored by ModernaTX.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
37,864 participants
Enrollment target
20
Study locations

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.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1403

Study Locations (20)

Arizona

  • ClinMed, LLC - Phoenix
  • DM Clinical - Phoenix - Phoenix
  • HOPE Research Institute - Phoenix
  • HOPE Research Institute - Phoenix
  • Abby's Research Institute - Phoenix
  • Headlands Research Scottsdale - Scottsdale
  • Scottsdale Clinical Trials - Scottsdale
  • Hope Research Institute - Tempe - Tempe
  • Arizona Liver Health - Tucson
  • Quality of Life Medical and Research Center - Tucson
  • Del Sol Research Management LLC.- Tucson - Tucson

California

  • ARK Clinical Research, LLC - Fountain Valley
  • ASCADA Research, LLC - Family Medicine - Fullerton
  • Matrix Clinical Research - Huntington Park
  • Velocity Clinical Research, San Diego - La Mesa

Alabama

  • Accel Research Sites - Achieve Clinical Research - Birmingham
  • Cullman Clinical Trials - Cullman
  • Alliance for Multispecialty Research, LLC - Daphne

Arkansas

  • Lynn Institute of the Ozarks - Little Rock
  • Baptist Health Center for Clinical Research - Little Rock

Trial Details

FieldValue
Enrollment Target 37,864 participants
Start Date 2024-09-24
Est. Completion 2027-02-15
Phase Phase 3
ModernaTX

90 total trials

What the registry record for NCT06592794 still lists

NCT06592794 is an interventional study that assigns participants to a tested intervention. Its 37,864 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (4817% higher).

The record links to 2 conditions, with Norovirus Acute Gastroenteritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06592794 names 20 study sites across 4 states, led by Arizona, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT06592794 about?

NCT06592794 is a clinical study titled "A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis". 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.

What is the current status of trial NCT06592794?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 37,864 participants. The study started on 2024-09-24. Estimated completion is 2027-02-15.

What conditions does trial NCT06592794 study?

This clinical trial studies the following conditions: Norovirus Acute Gastroenteritis, Acute Gastroenteritis.

What interventions are being tested in trial NCT06592794?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1403 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06592794?

This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06592794 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Norovirus Acute Gastroenteritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06592794's enrollment target sits among peer trials

37,864 3rd of 2000 higher than 1,998 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06592794, the US trial registry maintained by the National Library of Medicine. NCT06592794 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.