Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-21 @ 5:08 PM
Study NCT ID:
NCT06592794
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Sponsor:
ModernaTX, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nova 301
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: