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

Inclusion criteria

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

Exclusion criteria

• 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.
• 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.
• 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).
• 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.
• Individuals with known or suspected history of drug or alcohol abuse.
• 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.
• Individuals who were not able to comprehend and to follow all required study procedures for the whole period of the study.
• 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.
• Individuals who within the past 6 months have:

• had any laboratory confirmed seasonal or pandemic influenza disease;
• received any seasonal or pandemic influenza vaccine.
• 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.
• Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
• Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
• 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.
• Individuals who were part of study personnel or close family members conducting this study.
• BMI >35 kg/m2.