EUCTR2009-015588-15-Outside-EU/EEA进行中（未招募）不适用
SAFETY AND IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION. OPEN LABEL, RANDOMIZED, ACTIVE CONTROLLED, PHASE 3 STUDY
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
- 1,867
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
- •1Male or female healthy children and adolescents aged = 2 months to < 18 years at the time of first vaccination.
- •2Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- •3Female 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1867
- •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 of Japanese Encephalitis
- •2- History of Flavivirus vaccination (including any investigational vaccines)
- •3- History of vaccination with Prevnar® (only for children aged < 1 year) and HAVRIX®720
- •4- History of immunodeficiency or immunosuppressive therapy
- •5- Known HIV, HBV or HCV infection
- •6- History of hypersensitivity reactions to other vaccines
- •7- Acute febrile infection at each visit during which the subject receives a vaccination
- •8- For children aged = 6 months at first vaccination, active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to one week after the second IC51 vaccination. For children aged < 6 months, active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
研究者
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