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

Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor 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