NCT01246479已完成3 期
Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
研究概览
简要总结
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have received two vaccinations in study IC51
- •(2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-
- •Male or female healthy subjects aged ≥ 9 months to < 21 years at the time of enrolment into this study.
- •Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
排除标准
- •History of or clinical manifestation of any Flavivirus disease during study IC51-
- •Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
- •Participation in another study with an investigational product during study IC51-322 or IC51-
- •History of or development of any immunodeficiency including post-organtransplantation after inclusion into study IC51-
- •History of or development of an autoimmune disease during study IC51-
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-
- •(For corticosteroids this means prednisone or equivalent at >= 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
- •Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
- •Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
- •Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
结局指标
主要结局
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
时间窗: Month 12
Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
次要结局
- Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)(Months 12, 24 and 36)
- Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322).(Months 12, 24 and 36)
- GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)(Month 12, 24 and 36)
- Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)(Month 24, 36)
研究者
研究点 (5)
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