Influenza Vaccine in Pediatric Transplant Subjects
Completed · Phase 4
Conditions studied: Influenza
In brief
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-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.
Key facts
- Study ID
- NCT00133510
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 60
- Starts
- 2004-11-01
- Expected to finish
- 2006-09-01
- Last updated by the study team
- 2010-08-27
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mount Sinai Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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