NCT00735839已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
研究概览
简要总结
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Generally Good Physical Health
排除标准
- •Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
- •Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
时间窗: Baseline (Day 1) to Day 14 postvaccination
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Number of Participants With Vaccine-related Serious Adverse Experiences
时间窗: Baseline (Day 1) to Day 84 postvaccination
Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
次要结局
未报告次要终点
研究者
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