Clinical study in children, 6 months to 3 years of age, to assess two dose levels of an experimental flu vaccine, using a licensed influenza virus vaccine, Vaxigrip® as the control

A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;

• Subjects must be in good health established by medical history and physical examination before entering into the study;
• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
• Written informed consent obtained from the subject’s parent/guardian.
• Parents/guardian access to a consistent means of telephone contact, land line or mobile

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 to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
• History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
• Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
• Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
• Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
• Any use of analgesics/antipyretics 12 hours before receipt of vaccine.