Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785794
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2021-03-03
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:
FluGen Inc
Study Overview
Official Title:
Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 ASingaporeINFIMH-16-00192016 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 21 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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMID 20-0025 | OTHER_GRANT | NIAID | None |