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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 37,864 participants |
| Start Date | 2024-09-24 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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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
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Source ClinicalTrials.gov registry export · 2026-08-08
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