A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.

Inclusion Criteria:

1. Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months
2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
4. Be born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;

2. Previous influenza vaccination;

3. Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;

4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);

5. Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:

   •Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).

6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;

7. Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;

8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;

9. Have a known history of Guillain-Barré Syndrome;

10. Have a major congenital defect or serious illness and

11. Have a history of neurologic disorders or seizures