NCT00109122已完成2 期
A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- VZV ELISPOT response ~6 weeks after 1 and 2 doses
研究概览
简要总结
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).
详细描述
The duration of treatment is 12 weeks.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are at least 60 years of age with a history of varicella (shingles)
- •Females must have been postmenopausal.
排除标准
- •Subjects who did not previously participate in the main study of this protocol.
- •Subject had shingles since their 6 month follow-up visit in main phase of study.
结局指标
主要结局
VZV ELISPOT response ~6 weeks after 1 and 2 doses
时间窗: 6 weeks after 1 and 2 doses
次要结局
- To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo(1 through 3 years after vaccination)
研究者
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