Study of Safety and Immunogenicity of Fluzone® in Healthy Children

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from
healthy children receiving the 2004-2005 formulation of the inactivated, split-virion
influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),
Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Inclusion Criteria :

- Participant is aged ≥ 6 months to < 36 months.

- Participant is considered to be in good health on the basis of reported medical
history and limited physical examination.

- Participant is available for the duration of the study.

- Parent/guardian is willing and able to provide informed consent.

- Parent/guardian is willing and able to meet protocol requirements.

Exclusion Criteria :

- Reported allergy to egg proteins, chicken proteins, or any other constituent of the
vaccine.

- Previous history of influenza vaccination or documented history of influenza
infection.

- An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72
hours preceding enrollment in the trial (defer enrollment).

- Clinically significant findings in vital signs or review of systems (investigator
judgment; defer or exclude).

- Participation in any other clinical trial within 30 days prior to enrollment up to
termination of the subject's participation in the study.

- Known or suspected impairment of immunologic function, or receipt of
immunosuppressive therapy or immunoglobulin since birth.

- Personal or immediate family history of congenital immune deficiency.

- Developmental delay, neurologic disorder, or seizure disorder.

- Chronic medical, congenital, or developmental disorder.

- Known human immunodeficiency virus (HIV)-positive mother.

- Prior history of Guillain-Barré syndrome.

- Any condition which, in the opinion of the investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine.

- Any vaccination in the 14 days preceding enrollment in the study or scheduled between
Visit 1 and Visit 3.