Immunogenicity and safety of GSK Biologicals’ influenza vaccine versus a licensed comparator in children

A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.

• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject’s parent/guardian.

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.

• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
• Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.