Status:
COMPLETED
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
University of Pittsburgh
MCM Vaccines B.V.
Conditions:
Pediatric Solid Organ Transplant Patients
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transpl...
Detailed Description
A prospective, randomized, double-blind phase 1 safety and immunogenicity study of the HD compared with the SD TIV in pediatric patients between the ages of three and 17 yr that have undergone SOT (Cl...
Eligibility Criteria
Inclusion
- Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral)
- Must be at least 6 months after transplant.
- 3-17 years of age, inclusive.
- Available for duration of study.
- Parent or guardian able to be reached by phone.
Exclusion
- History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein.
- History of Guillian-Barre syndrome.
- Receipt of rituximab within the past one year.
- Rejection treatment with intravenous steroid bolus within 30 days.
- Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Have any condition that the investigator believes may interfere with successful completion of the study.
- History of received 2011-2012 influenza vaccine.
- Pregnant female.
- History of proven influenza disease after September 1, 2011.
- History of known infection with HIV, hepatitis B, or hepatitis C.
- History of known latex hypersensitivity.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01525004
Start Date
September 1 2011
End Date
December 1 2012
Last Update
August 16 2016
Active Locations (1)
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1
Monroe Carell Jr. Children's Hospital at Vanderbilt University
Nashville, Tennessee, United States, 37232