TCTR20220412006尚未招募4 期
Randomized controlled, investigator blinded, single center trial in Thailand in approximately 140 subjects aged 20-30 months whom had been primed with any live attenuated JE vaccine at least 12-18 months before booster dose of vaccine. Subjects will be randomized into 2 arms
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 140
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.Children (any gender) aged 20-30 months on day of enrollment, 2.History of recieved 1 dose of IMOJEV or CD JEVAX as primary JE vaccination at 12-18 months prior to enrollment for booster dose, 3.In good general health at enrollment, 4.Informed consent by parent(s) or legal gardian(s), 5.Able to follow up for 1 year (+1 month) after enrollment
排除标准
- •1.Acute febrile illness on day of vaccination (Body temperature is equal or more than 38 degree Celsius), 2.Had been recieved any JE vaccine before (except IMOJEV or CD JEVAX for 1 dose only), 3.Reciept of blood products in the past 3 months or plan to recieve blood product within 1 month after enrollment, 4.Known hypersensitivity of vaccine component, 5.Any confirmed or suspected immunosuppress or immunodeficient condition, by medical history or physical examination, 6.Had been recieved any vaccine within 30 days prior study vaccine, 7.Planned to recieve any vaccine within 30 days after enrollment, 8.Not participating in any clinical trial for drug or vaccine 30 days before and after enrollment.
研究者
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