Influenza
Conditions
Keywords
Influenza vaccine, Prophylaxis Influenza vaccine
Brief summary
The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.
Interventions
BIOLOGICALFluarix vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female age between 18 and 64 years at the time of the first vaccination. * non-childbearing female
Exclusion criteria
* 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 * Administration of any other influenza vaccine for the season 2006-2007 * Chronic disorders of the pulmonary or cardiovascular system, including asthma. * Administration of immune-modifying drugs * Administration of immunoglobulins and/or any blood products * History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of confirmed influenza | — |
Secondary
| Measure | Time frame |
|---|---|
| occurrence of influenza like illness | — |
| Occurrence of pneumonia | — |
| Immune response at days 0 and 21 | — |
| Safety during 7 Months | — |
Countries
Czechia, Finland
Outcome results
None listed