Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

Inclusion Criteria: * ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy * Recording of medical history and physical examination reveal no abnormality * The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization Exclusion criteria: * Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine * Previous vaccination against influenza * At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C * Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV) * Medical treatment (\>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed) * Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study * Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period * At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs * Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided) * Family history of Guillain-Barré Syndrome * Severe congenital deficiency or disease * Antecedent of neurological disease or epileptic attack * Severe cardiopulmonary disease with possibility to influence the study result * Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection * Suspected non-compliance