Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028347
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-08-31
Brief Title:
Safety Reactogenicity and Immunogenicity Study of a Self-Amplifying mRNA Influenza Vaccine in Healthy Adults
Sponsor:
Seqirus
Organization:
Seqirus
Study Overview
Official Title:
Phase 1 Randomized Placebo-Controlled Observer Blind Study to Evaluate the Safety Reactogenicity and Immunogenicity of an Investigational Self-Amplifying mRNA Influenza Vaccine in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 is a Phase 1 first-in-human randomized placebo-controlled observer blind study The effect of two doses of an investigational vaccine on safety reactogenicity kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults
Approximately 96 evaluable subjects will be enrolled in this study n72 receiving investigational vaccine and n24 receiving placebo
The study has a screening period Day -28 to Day -1 a treatment period Day 1 to Day 43 and a follow-up period Day 44 to Day 202
Approximately 96 evaluable subjects will be enrolled in this study n72 receiving investigational vaccine and n24 receiving placebo
The study has a screening period Day -28 to Day -1 a treatment period Day 1 to Day 43 and a follow-up period Day 44 to Day 202
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None