Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100399
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2004-12-30
Brief Title:
Fluarix Immunogenicity and Safety Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-blinded Placebo Controlled Phase III Study to Evaluate the Immunogenicity and Safety of GSK Bio Influenza Vaccine Fluarix Administered Intramuscularly in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2007-03
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 purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the USA Up to 1050 volunteers at 4 centers will receive Fluarix or Placebo saline and their responses will then be compared Subjects will be placed by age into 2 groups 18 to 49 years old and 50 to 64 years old then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle There will be 2 phases in this study 1 the active study phase 2 visits for all subjects and 2 the cross-over phase only for subjects enrolled in the placebo group who accept to receive Fluarix Blood samples will be obtained in order to measure immune response to the vaccine On the day of vaccination volunteers will receive a diary card to record information on symptoms experienced during the next 3 days Subject participation in either group will be up to 2 months
Detailed Description:
This study is a randomized double-blinded placebo controlled Phase III study to evaluate the immunogenicity and the safety of GSK Bio influenza vaccine Fluarix administered intramuscularly in healthy adults aged 18 to 64 years Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk Following vaccination seroprotective antibody titers are achieved in a high proportion of vaccinated subjects GlaxoSmithKline Biologicals GSK Bio has been marketing an inactivated influenza split vaccine Fluarix since 1992 More than 126 million doses have been distributed and the vaccine is registered in 78 countries It has been well tolerated and has proven to be highly immunogenic when injected by the intramuscular route
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 104233 | None | None | None |