Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-17
SponsorChildren's Mercy Hospital Kansas City
About this trial
The study is an interventional, non-randomized assessment of safety and efficacy of live Measles, Mumps and Rubella (MMR) vaccine in subjects aged 12-months to 17 years who have undergone heart transplantation. Subjects who provide permission/assent will receive the commercial MMR vaccine according to product indication and labeling.
Eligibility criteria
Qualifiers
Received a heart transplant
At least 1 year after transplant
At least 1 year after antibody-mediated rejection treatment (intravenous immune globulin, rituximab, bortezomib, plasmapheresis, carfilzomib, eculizumab, daratumumab)
At least 1 year from anti-thymocyte globulin
Disqualifiers
History of repeated infections necessitating adjustment in immunosuppression to non-standard regimen, including single agent immunosuppression and modified trough levels.
History of anaphylactic reaction to MMR vaccination
Trial design
Treatments tested in this trial
- Commercial measles, mumps, and rubella (MMR) vaccine
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov