- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133510
Influenza Vaccine in Pediatric Transplant Subjects
August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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, researchers will attempt to correlate the humoral and cell-mediated immune response with parameters that may predict a subject's ability to respond to the vaccine, such as time from transplant, immunosuppressive agents, previous episodes of rejection or cytomegalovirus infection, T-cell numbers and T-cell responses to mitogens or antigens.
Understanding the immune response to influenza will provide insight not only into the response to the trivalent subviron influenza vaccine but to other vaccines being developed against agents of bioterrorism, in particular those that may use influenza or related viruses as a backbone.
This is a single center, prospective comparative study of the humoral and cell-mediated immune responses to the trivalent subviron influenza vaccine for the 2004-2005 and 2005-2006 influenza seasons in outpatient pediatric liver transplant recipients and their healthy siblings.
There are two study arms, the liver transplant recipients (n=44) and the healthy controls (n=22).
All study subjects will receive the vaccine at enrollment.
Enrollment into this study will be extended into the 2005-2006 influenza season.
The trivalent subviron influenza vaccine for the 2005-2006 influenza season will differ from that for the 2004-2005 influenza season with respect to the H3N2 viral strains.
The cell-mediated and humoral immune responses of patients to the two H3N2 viral strains will be analyzed together and separately to assess potential differences in immunogenicity between the two viral strains.
Humoral and cell-mediated immune responses will be obtained at baseline and following immunization.
Healthy siblings are used as controls to ensure equal burden of influenza disease among study participants.
Participants will be involved in study related procedures for up to 8 months.
Study Type
Interventional
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
August 19, 2005
First Submitted That Met QC Criteria
August 19, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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