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.