Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07195032

Enrollment

Registered

2025-09-26

Start date

2025-09-11

Completion date

2027-09-11

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Infection Prevention

Keywords

Measles, Mumps, Rubella, Live vaccine, Heart transplant

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.

Interventions

DRUGCommercial measles, mumps, and rubella (MMR) vaccine

Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination	Between 0-240 days after vaccine administration	Patients will be screened for adverse reactions following vaccine administration
Number of participants with resultant initial seropositivity against measles after vaccination	Between 60-240 days after vaccine administration.	Serologic response will be measured after vaccine administration.

Secondary

Measure	Time frame	Description
Number of participants who experience prolonged seropositivity after vaccine administration	Minimum of 365 days after vaccine administration	Serologic response will be tested at least 365 days after final vaccine administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026