Status:
COMPLETED
Influenza Vaccine in Pediatric Transplant Subjects
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-...
Detailed Description
The purpose of this study is to investigate the humoral and cell-mediated immune response to the trivalent subviron influenza vaccine in pediatric liver transplant recipients. Additionally, researcher...
Eligibility Criteria
Inclusion
- Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely.
- Between the ages of 6 months and 17 years.
- Three months have elapsed since liver transplantation.
- Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant.
- Must have the ability to comply with the study procedures for the entire length of the study.
Exclusion
- Previous immunization with an influenza vaccine for the 2004-2005 or 2005-2006 influenza season.
- Known hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
- History of Guillian-Barré syndrome.
- Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination.
- Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment.
- Subjects who have experienced an acute febrile illness within the preceding 48 hours will have immunization deferred and be rescheduled once their fever has resolved.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00133510
Start Date
November 1 2004
End Date
September 1 2006
Last Update
August 27 2010
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029