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

Conditions

• Heart Transplant Infection Prevention

Eligibility Criteria

Sex

ALL

Age

1 Year - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Commercial measles, mumps, and rubella (MMR) vaccine — DRUG
  Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.

Study Details

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.

Key Dates

Start date

Sep 11, 2025

Status verified

Sep 2025

Primary completion

Sep 11, 2027

Completion

Sep 11, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Measles, Mumps, Rubella Vaccination
  Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles

Primary Outcome Measure

Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination [ Time Frame: Between 0-240 days after vaccine administration ]

Locations (1)

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