Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192309
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2005-09-12
Brief Title:
Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Randomized Open-Label Placebo-Controlled Trial to Investigate the Kinetics of the Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine TrivalentTypes A B Live Cold-Adapted CAIV-T in Healthy Adults Aged 18 to 65 Years
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The primary objective of this study was to perform a variety of assays on blood serum nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine trivalent types A B live cold-adapted liquid formulation CAIV-T Wyeth Marietta PA
Detailed Description:
This was a randomized open-label placebo-controlled outpatient study carried out in healthy adults 18 to 65 years of age The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies Subjects were randomized in a 111 ratio to receive a single dose of either CAIV-T inactivated influenza virus vaccine TIV or placebo
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