Status:
COMPLETED
Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Brief Summary
This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elde...
Detailed Description
This study will investigate the incidence of influenza, disease and various possible downstream complications, such as pneumonia, ischemic HD (unstable angina or MI), congestive heart failure, acute c...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All subjects must satisfy to the following criteria at study entry:
- (1) A male or female age 65 years at the time of the first vaccination,
- (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study
- (3) Written informed consent obtained from the subject
- (4) Availability to follow up by phone during the study period
- (5) Subjects with residence status allowing free mixing with general community.
- Exclusion Criteria
- The subject must not be included in the study for:
- (1) history of hypersensitivity to a previous dose of influenza vaccine
- (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,
- (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
1524 Patients enrolled
Trial Details
Trial ID
NCT00306982
Start Date
March 1 2006
End Date
December 1 2006
Last Update
October 12 2016
Active Locations (12)
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1
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
2
GSK Investigational Site
Umina, New South Wales, Australia, 2257
3
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
4
GSK Investigational Site
Kippa-Ring, Queensland, Australia, 4021