NCT01954810Unknown4 期
Assessment of Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Neutralizing antibody titers after JECV vaccination
研究概览
简要总结
This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.
详细描述
This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 72 Months 至 80 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
- •Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
- •Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
- •In good general health, based on medical history and physical examination
排除标准
- •Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
- •Planned participation in another clinical trial during the Day0-Day28 period
- •Receipt of live vaccine within 4 weeks preceding the trial vaccination
- •Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- •Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
结局指标
主要结局
Neutralizing antibody titers after JECV vaccination
时间窗: 28 days
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
次要结局
未报告次要终点
研究者
Pope Kosalaraksa
Associate Professor
Khon Kaen University
研究点 (2)
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