Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

Inclusion criteria

• 18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
• 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
• in good health as determined by:

• Medical history related to the previous six months,
• Physical examination,
• Clinical judgment of the investigator.

Exclusion criteria

• Unwilling or unable to give written informed consent to participate in the study
• Currently experiencing an acute infectious disease
• Any serious disease such as, for example:

• 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
• 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 expect to receive another vaccine within 3 weeks following the study vaccination
• Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
• Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
• Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
• Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.