Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
Inclusion Criteria:
Exclusion Criteria:
Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
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 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 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.