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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Varicella IgG Antibody Titer ≥ 1.1 IU/ml
研究概览
简要总结
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)
详细描述
Primary Aim:
To measure the antibody response to ProQuad® vaccination given earlier than the current recommended age in patients from the age of 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five years. These subjects would not reach the recommended ages to receive the vaccine before the transplant.
Hypothesis:
The Investigator proposes the hypothesis that the proposed study population will mount a clinically significant response to two (2) doses of the ProQuad® vaccine.
Primary Endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Open Label
Open Label. Two 0.5-mL doses of ProQuad® will be given by intramuscular injection at least 30 days but no more than 365 days apart..
干预措施: ProQuad (Biological)
结局指标
主要结局
Varicella IgG Antibody Titer ≥ 1.1 IU/ml
时间窗: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants with Varicella IgG Antibody Titer ≥ 1.1 IU/ml: at least 30 days to less than 365 days post vaccination.
Measles IgG Antibody Titer ≥ 30AU/ml
时间窗: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants with post vaccination Measles IgG Antibody Titer ≥ 30AU/ml: at least 30 days to less than 365 days post vaccination.
Mumps IgG Antibody Titer ≥ 11AU/ml
时间窗: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants tested for Mumps IgG Antibody Titer ≥ 11AU/ml: at least 30 days to less than 365 days post vaccination.
Rubella IgG Antibody Titer ≥ 15 IU/mL
时间窗: "at least 30 days to less than 365 days post vaccination"
Percentage of Participants tested for Rubella IgG Antibody Titer ≥ 15 IU/mL: at least 30 days to less than 365 days post vaccination.
次要结局
- Geometric Mean Titer (GMT) of Varicella Antibody("at least 30 days to less than 365 days post vaccination")
- Geometric Mean Titer (GMT) of Measles Antibody("at least 30 days to less than 365 days post vaccination")
- Geometric Mean Titer (GMT) of Mumps Antibody("at least 30 days to less than 365 days post vaccination")
- Geometric Mean Titer (GMT) of Rubella Antibody("at least 30 days to less than 365 days post vaccination")
研究者
Katherine Twombley
Associate Professor
Medical University of South Carolina