Status:
COMPLETED
Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the co...
Eligibility Criteria
Inclusion
- A male or female aged 18 years or above at the time of the vaccination;
- Healthy subjects or with well-controlled chronic diseases;
- If the subject is female, she must be of non-childbearing potential
Exclusion
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination 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 first vaccine dose.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Administration of an influenza vaccine within 6 months preceding the study start.
- Administration of an influenza vaccine other than the study vaccine during the entire study
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Not stabilized or clinically serious chronic underlying disease
- Lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00345904
Start Date
July 1 2006
End Date
August 1 2006
Last Update
September 28 2016
Active Locations (4)
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1
GSK Investigational Site
Dresden, Saxony, Germany, 01097
2
GSK Investigational Site
Dresden, Saxony, Germany, 01099
3
GSK Investigational Site
Dresden, Saxony, Germany, 01277
4
GSK Investigational Site
Freital, Saxony, Germany, 01705