Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant (NCT02687763) | Clinical Trial Compass
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 range
6 Months – 24 Months
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Varicella IgG Antibody Titer ≥ 1.1 IU/ml
Timeframe: "at least 30 days to less than 365 days post vaccination"
2
Measles IgG Antibody Titer ≥ 30AU/ml
Timeframe: "at least 30 days to less than 365 days post vaccination"
3
Mumps IgG Antibody Titer ≥ 11AU/ml
Timeframe: "at least 30 days to less than 365 days post vaccination"
4
Rubella IgG Antibody Titer ≥ 15 IU/mL
Timeframe: "at least 30 days to less than 365 days post vaccination"