NCT01047839已完成3 期
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
研究概览
简要总结
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
- •Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
- •Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
- •The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.
排除标准
- •Clinical manifestation or history of any Flavivirus disease
- •Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
- •History of immunodeficiency or immunosuppressive therapy
- •Known HIV, HBV or HCV infection
- •History of hypersensitivity reactions to other vaccines
- •Acute febrile infection at each visit during which the subject receives a vaccination
- •Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
结局指标
主要结局
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
时间窗: until Day 56
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
次要结局
- Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination(up to Month 7)
- Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination(up to Day 56 and upt to Month 7)
- Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination(up to Month 7)
- GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7(at Day 56 and Month 7)
- SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)(at Day 56 and Month 7)
- Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination(7 days)
- GMTs at Day 56 and Month 7 Stratified According to Age Groups(at Day 56 and Month 7)
- SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups(at Day 56 and Month 7)
研究者
研究点 (19)
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