EUCTR2010-022265-10-Outside-EU/EEA进行中（未招募）不适用
ONG TERM IMMUNITY AND SAFETY WITH OR WITHOUT A BOOSTER DOSE FOLLOWING PRIMARY VACCINATION WITH THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION IN A JEV-ENDEMIC COUNTRY. OPEN-LABEL, RANDOMIZED, 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
- 300
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.Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
- •2.Children who have received the dose confirmed for their age group.
- •3.Male or female healthy children and adolescents aged =9 months to <17 years and 7 months at the time of enrolment into this study.
- •4.Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- •5.Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche) at Visits 1, 2 and 2a as stipulated by the protocol. For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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.Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow fever, West e virus and Dengue fever at any time prior to or planned during the study.
- •2.History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51 325.
- •3.Participation in another study with an investigational drug during IC51 323 or IC51 325.
- •4.Planned active or passive immunization within 2 weeks before and 1 week after the IXIARO booster.
- •5.History of or development of any immunodeficiency including post-organ-transplantation after inclusion into IC51-323 or IC51 325.
- •6.History of or development of an autoimmune disease during study IC51-323 or IC51 325.
- •7.Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during IC51-323 or IC51 325. (For corticosteroids, this would mean prednisone or equivalent at >=0.05 mg/kg/day; topical and inhaled steroids are allowed).
- •8.Acute febrile infection at Visit 2 (only for the Booster Group).
- •9.Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
- •10.Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission during IC51-323 or IC51 325.
- •11.History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
- •12.Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus (HCV).
- •13.Illicit drug use and/or current drug or alcohol addiction.
- •14.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.
- •15.Persons who have been committed to an institution (by a court or by an authority).
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