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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 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. The trial reports 20 study locations across 4 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06592794
The ClinicalTrials.gov registry entry for NCT06592794 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 37,864 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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