To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from
healthy children receiving the 2007-2008 formulation of the inactivated, split-virion
influenza vaccine Fluzone® for further study.
- 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
- Parent/legal acceptable representative is willing and able to meet protocol
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the
- An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F
rectal; For children: temperature ≥ 99.5°F oral/axillary) 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 or planned 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 personal 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.
- Received any vaccinations within the preceding 14 days (enrollment may be deferred).