Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Exclusion Criteria

• •1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study.
• •2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
• •* Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment);
• •* Medically significant advanced congestive heart failure (ie. NYHA class III and IV);
• •* Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);
• •* Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);
• •* Diabetes mellitus type I;
• •* Poorly controlled diabetes mellitus type II;
• •* Advanced arteriosclerotic disease;
• •* History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);
• •* Acute or progressive hepatic disease;
• •* Acute or progressive renal disease;
• •* Severe neurological (es. Guillain-Barré syndrome) or psychiatric disorder;
• •* Severe asthma.
• •3. Individuals with 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 eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).
• •4. Individuals with 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.
• •5. Individuals with known or suspected history of drug or alcohol abuse.
• •6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
• •7. Individuals who were not able to comprehend and to follow all required study procedures for the whole period of the study.
• •8. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
• •9. Individuals who within the past 6 months have:
• •* had any laboratory confirmed seasonal or pandemic influenza disease;
• •* received any seasonal or pandemic influenza vaccine.
• •10. Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study.
• •11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
• •12. Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
• •13. Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
• •14. Individuals who were part of study personnel or close family members conducting this study.
• •15. BMI \>35 kg/m2.