Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192413
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2005-09-13
Brief Title:
Trial to Compare the Safety Tolerability and Efficacy of Influenza Virus Vaccine CAIV-T With Inactivated Influenza Vaccine Trivalent Types A B in Adults Aged 60 Years and Older Against Culture-confirmed Influenza
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Prospective Randomized Open-Label Controlled Trial to Compare the Safety Tolerability and Efficacy of Influenza Virus Vaccine Trivalent Types A B Live Cold-Adapted CAIV-T With Inactivated Influenza Vaccine Trivalent Types A B in Adults Aged 60 Years and Older
Status:
COMPLETED
Status Verified Date:
2012-03
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:
FluMist
Brief Summary:
To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine in adults aged at least 60 years at enrollment of a single intranasally IN -administered dose of a liquid formulation of influenza virus vaccineCAIV-T is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated TIV administered intramuscularly IM prior to the anticipated commencement of the influenza season
Detailed Description:
None
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