Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.

This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months

Inclusion Criteria:

• children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry

Exclusion Criteria:

• Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
• Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period.
• Known or suspected impairment/alteration of immune function
• History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function