Status:
COMPLETED
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE4
Brief Summary
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule...
Detailed Description
The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged ≥ 6 months to \< 36 months.
- Considered to be in good health on the basis of reported medical history and limited physical examination.
- Available for the duration of the study (44 days +4 days).
- Parent/guardian is willing and able to provide informed consent.
- Parent/guardian is willing and able to meet protocol requirements.
- Exclusion Criteria :
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- Previous history of influenza vaccination or 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 (defer enrollment).
- Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- Participation in any other 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.
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00836953
Start Date
September 1 2003
End Date
July 1 2004
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23510