A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 30
- 主要终点
- Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
研究概览
简要总结
This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant 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
- None
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster
排除标准
- •Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
- •Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
- •Subject has a history of seizure disorder
- •Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
- •Subject has received an inactivated vaccine within the past 14 days
- •Subject has received a live vaccine within the past 30 days
- •Subject has received immune globulin within the past 5 months
- •Subject has a recent history of fever (within the last 72 hours)
结局指标
主要结局
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
时间窗: 6 weeks postvaccination
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
时间窗: 6 weeks postvaccination
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (\<10 units/mL) to mumps at baseline
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
时间窗: 6 weeks postvaccination
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
时间窗: 6 weeks postvaccination
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA units/mL) to VZV at baseline
次要结局
- Geometric Mean Titer of Measles Antibodies(6 weeks postvaccination)
- Geometric Mean Titer of Mumps Antibodies(6 weeks postvaccination)
- Geometric Mean Titer of Rubella Antibodies(6 weeks postvaccination)
- Geometric Mean Titer of VZV (gpELISA) Antibodies(6 weeks postvaccination)