NCT00092430已完成3 期
A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 主要终点
- Percent of patients demonstrating adequate antibody titers 6 weeks following administration
研究概览
简要总结
The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.
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
- •Healthy children 12-23 months of age
排除标准
- •Previously had measles, mumps, rubella, or varicella
- •Compromised immune system
结局指标
主要结局
Percent of patients demonstrating adequate antibody titers 6 weeks following administration
次要结局
- Geometric mean titers (GMT) 6 weeks post vaccination
研究者
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