Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

Inclusion Criteria:

1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose
parents/legal guardians have given written informed consent prior to study entry.
Assent will be obtained from subjects according to age requirements of the ECs/IRBs;

2. In good health as determined by:

1. medical history,

2. physical examination,

3. clinical judgment of the Investigator;

3. Able to comply with all study procedures and available for all clinic visits and
telephone calls scheduled in the study.

Exclusion Criteria:

1. Any serious disease, such as:

1. cancer,

2. autoimmune disease (including rheumatoid arthritis),

3. diabetes mellitus,

4. chronic pulmonary disease,

5. acute or progressive hepatic disease,

6. acute or progressive renal disease;

2. History of any anaphylaxis or serious reaction following administration of vaccine,
or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein,
neomycin, polymyxin, or any other vaccine component, chemically related substance, or
component of the potential packaging materials;

3. Known or suspected impairment/alteration of immune function, including:

1. use of immunosuppressive therapy such as systemic corticosteroids known to be
associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or
chronic use of inhaled high-potency corticosteroids within 60 days prior to
Visit 1,

2. cancer chemotherapy,

3. receipt of immunostimulants within 60 days prior to Visit 1,

4. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
derivatives within 3 months prior to Visit 1 or planned during the full length
of the study,

5. known HIV infection or HIV-related disease;

4. History of Guillain-Barré syndrome;

5. Bleeding diathesis;

6. Surgery planned during the study period;

7. Receipt of another investigational agent within 90 days, or before completion of the
safety follow-up period in another study, whichever is longer, prior to enrollment
and unwilling to refuse participation in another clinical study through the end of
the study;

8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for
live vaccines) prior to Visit 1;

9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;

10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine
in one influenza season;

11. Receipt of an influenza vaccine within 6 months prior to Visit 1;

12. Experienced a temperature 38.0°C [100.4°F]) and/or any acute illness within 3 days
prior to Visit 1;

13. Pregnant or nursing mother;

14. Female of childbearing potential who is sexually active and has not used acceptable
birth control measures for at least 2 months prior to study entry and who does not
plan to use acceptable birth control measures during the 3 weeks following
vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral,
injected, inserted or implanted hormonal contraceptive, diaphragm or condom with
spermicidal agent or intrauterine device are considered acceptable forms of birth
control;

15. Children of research staff or those living with research staff directly involved with
the clinical study. Research staff are individuals with direct study subject contact,
indirect contact with study subjects, or study site personnel who have access to any
study documents containing subject information. This would include receptionists,
persons scheduling appointments or making screening calls, regulatory specialists,
laboratory technicians, etc.;

16. Any condition, which in the opinion of the Investigator, might interfere with the
evaluation of the study objectives.