Fluarix Immunogenicity and Safety Trial

Exclusion Criteria

• •1. 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.
• •2. Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• •3. 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. (For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day.)
• •4. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• •5. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
• •6. History of hypersensitivity to a previous dose of influenza vaccine.
• •7. History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate.
• •8. Previous vaccination against influenza (2004-2005 influenza vaccine) within the 9 months prior to enrollment.
• •9. Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F)).
• •10. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• •11. Major congenital defects or serious chronic illness.
• •12. History of any neurologic disorders, including history of Guillain Barré syndrome
• •13. History of seizures, with the exception of a single febrile seizure during childhood.
• •14. Pregnant or lactating female.
• •15. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of enrollment in this study.
• •16. Has an underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS.
• •17. 18 years of age and on chronic aspirin therapy
• •18. Residents of nursing homes and long term care facilities.
• •19. Health care workers involved in direct patient care.
• •20. Out-of-home caregivers and household contacts of children \<6 months.