Status:
COMPLETED
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current...
Eligibility Criteria
Inclusion
- A male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or Fluarix during a clinical study organized during the preceeding year
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- History of confirmed influenza infection since a year from the date of previous vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Key Trial Info
Start Date :
October 3 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2005
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00318058
Start Date
October 3 2005
End Date
November 4 2005
Last Update
May 8 2017
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000