Status:
COMPLETED
Trial to Collect Safety Data and Sera for Immunogenicity Testing
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE4
Brief Summary
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...
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 (5.5 lbs).
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00389857
Start Date
October 1 2006
End Date
July 1 2008
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23510