Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Measles, Mumps, Rubella Vaccination
Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles
干预措施: Commercial measles, mumps, and rubella (MMR) vaccine (Drug)
结局指标
主要结局
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination
时间窗: Between 0-240 days after vaccine administration
Patients will be screened for adverse reactions following vaccine administration
Number of participants with resultant initial seropositivity against measles after vaccination
时间窗: Between 60-240 days after vaccine administration.
Serologic response will be measured after vaccine administration.
次要结局
- Number of participants who experience prolonged seropositivity after vaccine administration(Minimum of 365 days after vaccine administration)
研究者
Victoria Blazek
Clinical Pharmacy Specialist
Children's Mercy Hospital Kansas City