Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

Trial for annual approval of interpandemic influenza vaccines

Inclusion Criteria:

• 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
• able to comply with all the study requirements;
• in general good health as determined by: medical history; physical examination; clinical judgment of the investigator.

Exclusion Criteria:

• They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis);e. Acute or progressive hepatic disease; Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma.

• They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
• They have a 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:

receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - receipt of immunostimulants; - receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease;

• They have a known or suspected history of drug or alcohol abuse;
• They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
• Within the past 12 months, they have received more than one injection of influenza vaccine;
• Within the past 6 months, they have:

had laboratory confirmed influenza disease; received influenza vaccine;

• Within the past 4 weeks they have received:

another vaccine; any investigational agent;

• They have any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
• They have experienced an acute exacerbation of a COPD within the past 14 days;
• They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days;
• They are taking part in another clinical study;
• They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
• They are severely obese with Body Mass Index (BMI) > 35