Status:
COMPLETED
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE4
Brief Summary
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circula...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00258817
Start Date
October 1 2005
End Date
August 1 2007
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23510