Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592794
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
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:
None
Organization:
None
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:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None