NCT07195032 Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
| NCT ID | NCT07195032 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Mercy Hospital Kansas City |
| Condition | Heart Transplant Infection Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2027-09-11 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: * 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 * At least 6 months after pulse dose steroid treatment or basiliximab treatment * No history of MMR vaccination OR History of MMR vaccination but seronegativity for measles at time of inclusion * Clinically well Exclusion Criteria: * 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