Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576702
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2020-09-17
Brief Title:
Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Sponsor:
Seqirus
Organization:
Seqirus
Study Overview
Official Title:
A Phase 2 Randomized Stratified Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults
Status:
COMPLETED
Status Verified Date:
2024-04
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 2 randomized observer-blind active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators at 120 participants per group Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection The primary immunogenicity analysis is based on Day 29 serum
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?:
None
Is an FDA AA801 Violation?:
None