CompletedEarly Phase 1

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

United States5 participantsStarted 2015-12

Plain-language summary

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)

Who can participate

Age range6 Months – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Varicella IgG Antibody Titer ≥ 1.1 IU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Measles IgG Antibody Titer ≥ 30AU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Mumps IgG Antibody Titer ≥ 11AU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Rubella IgG Antibody Titer ≥ 15 IU/mL

Timeframe: "at least 30 days to less than 365 days post vaccination"

Trial details

NCT IDNCT02687763

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-03

View on ClinicalTrials.gov More RENAL INSUFFICIENCY, CHRONIC trials

Who can participate

Age range6 Months – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Varicella IgG Antibody Titer ≥ 1.1 IU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Measles IgG Antibody Titer ≥ 30AU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Mumps IgG Antibody Titer ≥ 11AU/ml

Timeframe: "at least 30 days to less than 365 days post vaccination"

Rubella IgG Antibody Titer ≥ 15 IU/mL

Timeframe: "at least 30 days to less than 365 days post vaccination"