NCT00605085已完成3 期
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,675
- 主要终点
- Safety and Tolerability up to Day 56
研究概览
简要总结
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
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
- •At least 18 years of age
- •Written informed consent obtained prior to study entry
排除标准
- •Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •History of any previous JE vaccination (e.g. JE-VAX®)
- •Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •A family history of congenital or hereditary immunodeficiency
- •History of autoimmune disease
- •Any acute infections within 2 weeks prior to enrollment
- •Known or suspected HIV Infection
- •Pregnancy, lactation or unreliable contraception in female subjects
结局指标
主要结局
Safety and Tolerability up to Day 56
时间窗: Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
次要结局
- Changes in Laboratory Parameters(until Day 56)
- Rates of Serious Adverse Events and Medically Attended Adverse Events(until Day 56)
- SCR and GMT of Subjects With Concomitant Vaccinations(until Day 56)
研究者
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进行中（未招募）
不适用
Safety and tolerability of the Japanese encephalitis vaccine IC51 (JE-PIV). Double blind, randomized, placebo controlled phase 3 study - IC51- 302Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide.EUCTR2005-000100-14-DEIntercell AG2,680