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NCT05992935 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
A Phase 1 study of Norovirus Acute Gastroenteritis, sponsored by ModernaTX.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 1,405
- Enrollment target
- 16
- Study locations
NCT05992935 is a Phase 1 study of Norovirus Acute Gastroenteritis that is actively recruiting participants, run by ModernaTX. The registered enrollment target is 1,405 participants. The trial reports 16 study locations across 14 states.
The verdict
NCT05992935, a Phase 1 study of Norovirus Acute Gastroenteritis, is actively recruiting participants, sponsored by ModernaTX.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 1,405 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1403
- BIOLOGICAL mRNA-1405
Study Locations (16)
Nebraska
- Velocity Clinical Research - Norfolk
- Velocity Clinical Research - Omaha
Other
- Emeritus Research Camberwell - Camberwell
- Nucleus Network - Melbourne
California
- ARK Clinical Research, LLC - Long Beach
Colorado
- Tekton Research, Inc - Longmont Center - Longmont
Florida
- Research Centers of America - Hollywood
Georgia
- Accel Research Sites Network - Decatur
Idaho
- Velocity Clinical Research - Boise - Meridian
Illinois
- Optimal Research - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,405 participants |
| Start Date | 2023-08-25 |
| Est. Completion | 2026-09-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05992935
The ClinicalTrials.gov registry entry for NCT05992935 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 1,405 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 1 condition, with Norovirus Acute Gastroenteritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05992935 reports 16 study locations spanning 14 distinct geographic areas - top geographies include Nebraska, Other, California.
Frequently Asked Questions
What is clinical trial NCT05992935 about?
NCT05992935 is a clinical study titled "Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age". The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactoge...
What is the current status of trial NCT05992935?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,405 participants. The study started on 2023-08-25. Estimated completion is 2026-09-22.
What conditions does trial NCT05992935 study?
This clinical trial studies the following conditions: Norovirus Acute Gastroenteritis.
What interventions are being tested in trial NCT05992935?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1403 (BIOLOGICAL), mRNA-1405 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05992935?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05992935 being conducted?
This trial has 16 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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