Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

Inclusion criteria

• Subjects eligible for enrollment into this study are male and female adults who are:

• ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
• able to comply with all study requirements
• in 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;
• Advanced congestive heart failure;
• Chronic obstructive pulmonary disease (COPD);
• Autoimmune disease (including rheumatoid arthritis);
• Acute or progressive hepatic disease;
• Acute or progressive renal disease;
• Severe neurological or psychiatric disorder;
• 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;
• Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
• 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 infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days