Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant

Completed · Early Phase 1

Conditions studied: RENAL INSUFFICIENCY, CHRONIC, LIVER FAILURE, ACUTE, HEART DISEASE

In brief

A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney)

Key facts

Study ID

NCT02687763

Run by

Medical University of South Carolina

People needed

5

Starts

2015-12-01

Expected to finish

2016-11-03

Last updated by the study team

2019-02-12

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent and/or legal guardian willing and able to give informed consent.
• Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
• to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
• to participate in the three (3) antibody titer blood draws.

You may not qualify if…

• History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
• Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
• Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
• Any condition which causes the investigator to determine that the subject is not appropriate to enroll.

Where it is running

• Medical University of South Carolina, Pediatric Nephrology — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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