Status:
COMPLETED
Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
Eligibility Criteria
Inclusion
- A male or female age 50 years or older at the time of the first vaccination.
- non-childbearing female
- Availability to follow up by phone
- Subjects with residence status allowing free mixing with general community
Exclusion
- Use of non-registered products
- Pregnancy
- Hypersensitivity to a previous dose of influenza vaccine
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
- Any contra-indication to intramuscular administration of Fluarix™
- For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination
Key Trial Info
Start Date :
October 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2007
Estimated Enrollment :
3054 Patients enrolled
Trial Details
Trial ID
NCT00377611
Start Date
October 5 2006
End Date
June 20 2007
Last Update
October 9 2018
Active Locations (37)
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1
GSK Investigational Site
Mobile, Alabama, United States, 36608
2
GSK Investigational Site
Delray Beach, Florida, United States, 33484
3
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
4
GSK Investigational Site
Las Vegas, Nevada, United States, 89104