Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Inclusion Criteria:

- Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).

- 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/legal acceptable representative is willing and able to provide informed
consent.

- Parent/legal acceptable representative is willing and able to meet protocol
requirements.

- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

Exclusion Criteria:

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

- 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 (Enrollment may be deferred).

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

- Participation in any other interventional 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.