Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170547
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2005-09-09
Brief Title:
Comparison of Delivery Routes of Flu Vaccine in Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunogenicity and Safety of a Split Inactivated Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With FluzoneR in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2006-07
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 protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years
Detailed Description:
This is a multi-center randomized partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination After the completion of the trial all subjects will be offered influenza vaccine of the 2005-2006 formulation
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