Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216242
Status:
UNKNOWN
Last Update Posted:
2006-12-11
First Post:
2005-09-20
Brief Title:
Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 yo
Sponsor:
ID Biomedical Corporation Quebec
Organization:
ID Biomedical Corporation Quebec
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy of Fluviral Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 goal of this study is to determine whether Fluviral an inactivated injectable trivalent influenza vaccine flu shot is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine
Detailed Description:
Yearly influenza flu epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly Injectable flu vaccines are generally believed to be effective but formal studies using modern culture methods to prove this are limited This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults a group at low risk for serious influenza complications who have received Fluviral an injectable flu vaccine with the rate of such illnesses in healthy younger adults who have received an injection of saline salt water The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups and the immune responses to the vaccine measured
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