NCT00595465已完成3 期
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 4
- 主要终点
- Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
研究概览
简要总结
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test
排除标准
- •History of immunodeficiency or immunosuppressive therapy,
- •Known Human Immunodeficiency Virus (HIV); OR
- •Drug addiction including alcohol dependence
研究组 & 干预措施
IC51 Batch A
Active Comparator
干预措施: Japanese Encephalitis purified inactivated vaccine (Biological)
IC51 Batch B
Active Comparator
干预措施: Japanese Encephalitis purified inactivated vaccine (Biological)
IC51 Batch C
Active Comparator
干预措施: Japanese Encephalitis purified inactivated vaccine (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
时间窗: Day 56
次要结局
- Seroconversion Rate(Day 56)
- Safety and Adverse Events(Day 56)
研究者
研究点 (4)
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