Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 transplantation (SOT).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborators: MCM Vaccines B.V.; Sanofi Pasteur MSD; University of Pittsburgh
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.