NCT01559831撤回1 期
Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Seroconversion rate (SCR) at Day 28
研究概览
简要总结
IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.
详细描述
IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.
A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
- •In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
- •Written informed consent obtained from the subject prior to any study-related procedures
排除标准
- •Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
- •Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
- •Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
- •Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
- •Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
- •Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
- •Persons who are committed to an institution
- •At Day 0, upcoming scheduled travel to a JE endemic region
结局指标
主要结局
Seroconversion rate (SCR) at Day 28
时间窗: at Day 28
次要结局
- SCR at Day 0(Day 0)
- Geometric Mean Titer at Day 0 and 28(Day 0 and Day 28)
- Rate of Adverse Events up to Day 28(Day 28)
研究者
研究点 (2)
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