Ignite Creation Date:
2025-12-23 @ 10:22 PM
Ignite Modification Date:
2025-12-23 @ 10:22 PM
Study NCT ID:
NCT07291635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
Sponsor:
Aramis Biotechnologies Inc.
Organization:
Study Overview
Official Title:
A Randomized, Observer-Blind, Adaptive, Active Comparator-Controlled, Dose-Ranging, Multicenter, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine in Adults 18 Years of Age and Older
Status:
NOT_YET_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:
None
Brief Summary:
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: