Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232947
Status:
COMPLETED
Last Update Posted:
2007-01-22
First Post:
2005-10-03
Brief Title:
Study Comparing Immune Response to and Safety of Fluviral and Fluzone Influenza Vaccines in Persons 50 yo and Over
Sponsor:
ID Biomedical Corporation Quebec
Organization:
ID Biomedical Corporation Quebec
Study Overview
Official Title:
A Non-Inferiority Comparison of Fluviral Influenza Vaccine to a US Licensed Inactivated Split-Virion Vaccine Fluzone in Adults 50 Years Old Living in the Community
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether the immune responses induced by Fluviral the investigational vaccine are comparable to those induced by Fluzone which is an influenza vaccine currently licensed in the US The study focuses on persons 50 years old and over In addition the study will compare the rate of reactions to the two vaccines and the general health of persons who receive them over the 42 days after immunization
Detailed Description:
Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population and also cause lost work and productivity among the healthy working elderly Fluviral a product now licensed in Canada is being tested to determine whether it is as active in causing immune responses and as safe as a currently licensed US vaccine in persons 50 yo and over
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