Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Fluzone®, Influenza Virus Vaccine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Influenza Virus Vaccine Naïve
Influenza Virus Vaccine-primed
Subjects have never received Influenza virus vaccine in the past
Subjects have received Influenza virus vaccine in the past