Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

Exclusion Criteria

• •Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:
• •1. Any serious chronic or acute disease such as:
• •1. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
• •2. Congestive heart failure
• •3. Advanced arteriosclerotic disease
• •4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
• •5. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
• •6. Insulin dependent diabetes mellitus
• •7. Acute or progressive hepatic disease
• •8. Acute or progressive renal disease
• •9. Severe neurological or psychiatric disorder
• •2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances
• •3. Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:
• •1. Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study,
• •2. Receipt of immunostimulants,
• •3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
• •4. Suspected or known HIV infection or HIV-related disease.
• •4. Known or suspected history of drug or alcohol abuse
• •5. Bleeding diathesis or receive anticoagulants of the coumarin type
• •6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days)
• •7. Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months
• •8. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start
• •9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
• •10. Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry
• •11. Simultaneous participation in another clinical study
• •12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.