Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006146
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2000-08-07
Brief Title:
Half-Dose Flu Vaccine Study in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2005-11
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:
It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old
If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose this could be a strategy to extend the amount of vaccine that could be available in this age group
If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose this could be a strategy to extend the amount of vaccine that could be available in this age group
Detailed Description:
Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm Prior to vaccination subjects will have one tube of blood drawn Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination A second blood draw will be done
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: