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

NCT ID: NCT07195032

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2027-09-11

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplant Infection Prevention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Measles, Mumps, Rubella Vaccination

Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles

Group Type EXPERIMENTAL

Commercial measles, mumps, and rubella (MMR) vaccine

Intervention Type DRUG

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

Interventions

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Commercial measles, mumps, and rubella (MMR) vaccine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Victoria Blazek

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victoria Blazek, PharmD, BCPPS

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Victoria Blazek, PharmD, BCPPS

Role: primary

816-302-3724

Other Identifiers

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STUDY00003689

Identifier Type: -

Identifier Source: org_study_id

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