Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04537234
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2020-08-26
Brief Title:
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine QIV-HD Compared to a Standard-Dose Quadrivalent Influenza Vaccine QIV-SD in Taiwanese Adults 65 Years of Age and Older
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Primary Objective
Immunogenicity To describe the immune response induced by high-dose quadrivalent influenza vaccine QIV-HD and AdimFlu-S QIS by hemagglutinin inhibition HAI measurement method in all participants
Safety To describe the safety profile of all participants in each study groups
Immunogenicity To describe the immune response induced by high-dose quadrivalent influenza vaccine QIV-HD and AdimFlu-S QIS by hemagglutinin inhibition HAI measurement method in all participants
Safety To describe the safety profile of all participants in each study groups
Detailed Description:
The duration of each participants participation was approximately 28 days Day 0 through Day 28 7 days
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1238-1970 | OTHER | UTN | None |