NCT00595790已完成3 期
Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- SCR (Seroconversion Rate) at Day 56
研究概览
简要总结
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years
详细描述
This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.
Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.
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
- Single (Participant)
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
- •History of clinical manifestation of any flavivirus infection
- •History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- •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
- •Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •A family history of congenital or hereditary immunodeficiency
- •History of autoimmune disease
- •Any acute infections within 4 weeks prior to enrollment
- •Infection with HIV, Hepatitis B or Hepatitis C
- •Pregnancy, lactation or unreliable contraception in female subjects
结局指标
主要结局
SCR (Seroconversion Rate) at Day 56
时间窗: day 56
Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer
次要结局
- SCR at Day 10, 28 and 35(Day 10, 28 and 35)
- GMT at Day 10, 28, 35 and 56(Day 10, 28, 35 and 56)
- Safety(Study duration)
研究者
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