TCTR20190507007尚未招募4 期
Safety and Immunogenicity of a booster dose of inactivated Vero-cell-derived Japanese Encephalitis vaccine (JEVAC) in children whom primed with live attenuated JE vaccine.
iaoning Cheng Biotechnology, Shenyang0 个研究点目标入组 150 人开始时间: 2019年5月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Months 至 30 Months（—）
- 性别
- All
入选标准
- •1. Healthy 20-30 months old
- •2. Available vaccination record
- •3. Received live-attenuate JE vaccine (CD.JEVAX) OR
- •chimeric JE vaccine (IMOJEV) as a primary dose 12-18 months
- •4. Be able to return for visit 3 times in a year for the follow-ups
- •5. Has not been vaccinated any vaccines one month prior the enrollment date
排除标准
- •1. No allergic reaction to any vaccine or any compartment in JE vaccine
- •2. Has fever or other symptoms diagnosed by physician on enrollment day
- •3. Plan to relocate by the end of the study
- •4. Has blood transfusion 3 months prior the enrollment date or expect to have blood transfusion within 1 month after vaccination
- •5. Suspected of having immunodeficiency, including severe liver disease, renal failure, growth disorders, cancer, autoimmune diseases, use of immunosuppressants, oral steroids (Except for respiratory spray steroid)
- •6. Parents or guardian refuse or unable to sign inform consent
研究者
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