Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 6:21 AM
Study NCT ID:
NCT04785794
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2021-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Sponsor:
FluGen Inc
Organization:
Study Overview
Official Title:
Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.
Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years. Eligible subjects will be randomized 2:1 to receive one administration of Sing2016 M2SR or placebo followed by a dose of age-appropriate licensed inactivated influenza vaccine (IIV) at least 28 days later. Two lead-in groups of adults ages 50-64 years (Cohort 1) and 65 - 85 years (Cohort 2) will be followed by enrollment of an expansion group, ages 65 - 85 (Cohort 3). Safety data will be reviewed between enrollment of successive cohorts.
Study Oversight
Has Oversight DMC:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DMID 20-0025 | OTHER_GRANT | NIAID | View |