A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 主要终点
- Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
研究概览
简要总结
This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.
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
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health
- •Negative clinical history of varicella, shingles, measles, mumps, and rubella
排除标准
- •Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
- •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
- •Immune globulin or any blood product administered in the past 3 months
研究组 & 干预措施
1
ProQuad™ (V221) + Placebo Followed by ProQuad™
干预措施: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological)
1
ProQuad™ (V221) + Placebo Followed by ProQuad™
干预措施: Comparator: Placebo (Biological)
2
M-M-R™ II + VARIVAX™
干预措施: Comparator: Varivax (Biological)
2
M-M-R™ II + VARIVAX™
干预措施: Comparator: M-M-R II (Biological)
结局指标
主要结局
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
时间窗: 6 weeks Postvaccination
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
次要结局
- Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline(6 weeks Postvaccination)
- Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL(6 weeks Postvaccination)
- Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL(6 weeks Postvaccination)
- Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL(6 weeks Postvaccination)