Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283283
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2006-01-24
Brief Title:
Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine TIV to Full Dose
Status:
COMPLETED
Status Verified Date:
2021-02
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 study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season
Detailed Description:
This was a Phase II prospective single-blind to dose randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone compared to full-dose Fluzone 2004-2005 formulation 1440 healthy subjects ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines were divided into 8 strata based on age gender and previous exposure to influenza vaccine and randomized to receive either half-dose 025mL Fluzone or full-dose 05mL Fluzone by intramuscular injection into the deltoid muscle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None