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
Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
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November 2004
Date type not reportedThis date has not been verified as actual or estimated.
August 19, 2005
Actual (reported)August 23, 2005
Actual (reported)September 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Mount Sinai Hospital
New York, New York, 10029, United States
First Submitted
August 19, 2005
First Posted
August 23, 2005
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2006
Date type not reportedProteomic Profiling for Influenza
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
August 27, 2010
Record last verified: 2008-03
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Source: ClinicalTrials.gov.
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