Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

Inclusion criteria

• 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
• mentally competent to understand the nature, the scope and the consequences of the study
• able and willing to give written informed consent prior to study entry
• available for all the visits scheduled in the study
• residence in the study area
• in good health as determined by:

• medical history,
• physical examination,
• clinical judgment of the investigator.

Exclusion criteria

• unable or unwilling to give written informed consent to participate in the study
• suffering from an acute infectious disease
• any serious disease such as:

• cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
• autoimmune disease (including rheumatoid arthritis),
• advanced arteriosclerotic disease or complicated diabetes mellitus,
• chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
• acute or progressive hepatic disease,
• acute or progressive renal disease,
• congestive heart failure
• surgery planned during the study period
• bleeding diathesis
• history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
• known or suspected impairment/alteration of immune function resulting from:

• receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
• receipt of immunostimulants,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
• high risk for developing an immunocompromising disease within the past 6 months
• history of drug or alcohol abuse
• laboratory confirmed influenza disease in the past 6 months
• received influenza vaccine within the past 6 months
• received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
• any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
• pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
• any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.