EUCTR2009-015595-10-DK进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1- Male or female healthy children and adolescents aged = 2 months to < 18 years at the time of first vaccination
- •2- Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
- •3- Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche). For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4. is required
- •4- 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 Day 35 to 56 or between Day 56 to Month 7
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1- Clinical manifestation or history of any Flavivirus disease
- •2- Vaccination against JE (except within this protocol), Yellow fever, West e virus and Dengue at any time prior or during the study
- •3- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
- •4- 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 prior to the first vaccination at Visit 1
- •5- Immunodeficiency including post-organ-translpantation or a family history of congenital or hereditary immunodeficiency.
- •6- History of autoimmune disease.
- •7- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 4 weeks prior to vaccination at Visit 1 and during the study (For corticosteroids, this will mean prednisone, or equivalent, = 0.05 mg/kg/day. Topical and inhaled steroids are allowed.).
研究者
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