Influenza Vaccine in Pediatric Transplant Subjects - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
Clinical Trial: Influenza Vaccine in Pediatric Transplant Subjects
This study is currently recruiting patients.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) May 2005
|Influenza || Vaccine: Trivalent Subviron Influenza vaccine (Fluzone) |
MedlinePlus related topics: Influenza
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Prospective Comparative Study of the Humoral and Cell Mediated Immune Responses to the Trivalent Subviron Influenza Vaccine in Pediatric Liver Transplant Recipients as an Indicator for Response of Immunocompromised Subjects to Vaccination Against Agents of Bioterrorism
Expected Total Enrollment: 66
Study start: November 2004; Expected completion: February 2008
Accepts Healthy Volunteers
Study subjects must meet all of the following inclusion criteria to participate in this study.
- 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 time has 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.
Any subject meeting any one of the exclusion criteria at enrollment or at the time of subsequent vaccination will be excluded from participation in the study. In addition, 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.
Exclusion criteria include:
- Previous immunization with an influenza vaccine for the 04-05 influenza season.
- Known Hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
- History of Guillian-Barre 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.
Location and Contact Information
Mount Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Last Updated: August 22, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00133510
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23