NCT00604708已完成3 期
Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 867
- 主要终点
- SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
研究概览
简要总结
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX 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
- 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)of IC51 Compared to JE-VAX at Day 56
时间窗: Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
时间窗: Day 56
GMT: geometric mean of PRNT50
次要结局
- Safety and Adverse Events(until Day 56)
- Immunogenicity at Day 56 for North America vs. Europe(Day 56)
- Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age(Day 56)
- Immunogenicity at Day 28(Day 28)
研究者
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