Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

The study is to collect sera from healthy children being administered the 2003-2004
formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Inclusion Criteria :

- Aged ≥ 6 months to < 36 months.

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

- Available for the duration of the study (44 days +4 days).

- 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.