EUCTR2015-005193-38-Outside-EU/EEA进行中（未招募）不适用
A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Sanofi Pasteur SA0 个研究点目标入组 300 人开始时间: 2015年11月17日最近更新:
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
- 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. Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
- •2. Completion of vaccinations according to the national immunization schedule
- •3. Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- •4. Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
- •5. Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
- •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. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •2. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •3. Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- •4. Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •5. Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
- •6. Receipt of hepatitis A vaccine.
- •7. History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
- •8. Administration of any anti-viral within 2 months preceding the screening visit.
- •9. History of central nervous system disorder or disease.
- •10. Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- •11. Planned participation in another clinical trial during the present trial period.
- •12. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •13. Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
- •14. Personal human immunodeficiency virus, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
- •15. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
- •16. Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
- •17. Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
- •History of seizures.
- •18. Previous vaccination against flavivirus disease.
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