Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 801
- 主要终点
- Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
研究概览
简要总结
The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health
- •Received primary dose of M-M-R II at less than or equal to 12 months of age
- •Received primary dose of Varivax at less than or equal to 12 months of age
- •Negative history of varicella, zoster, measles, mumps, and rubella
排除标准
- •history of receiving more than once dose of M-M-R II or Varivax
- •Any immune impairment or deficiency
- •Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
- •Vaccination with an inactive vaccine with in the past 14 days
- •Vaccination with a live vaccine within the past 30 days
- •Receipt of immune globulin, or blood product in the past 5 months
研究组 & 干预措施
1
ProQuad + Placebo
干预措施: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (Biological)
1
ProQuad + Placebo
干预措施: Comparator: Placebo (Biological)
2
M-M-R II + Placebo
干预措施: Comparator: M-M-R II (Biological)
2
M-M-R II + Placebo
干预措施: Comparator: Placebo (Biological)
3
M-M-R II + Varivax
干预措施: Comparator: M-M-R II (Biological)
3
M-M-R II + Varivax
干预措施: Comparator: Varivax (Biological)
结局指标
主要结局
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Measles
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
时间窗: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Varicella
次要结局
未报告次要终点