TCTR20221102003已完成4 期
Study of long term immunogenicity of a live attenuated SA14-14-2 JE Vaccine (CD.JEVAX) as a booster dose after priming with chimeric JE Vaccine (IMOJEV) in Thai children.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
A Booster dose of CDJEVAX vaccination elicits very strong immune responses in children previously vaccinated with IMOJEV, indicated interchangeability of these 2 vaccines. Statistical models predicted individual neutralizing antibody titres and seroprotection up to 10 years postvaccination.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Years 至 5 Years（—）
- 性别
- All
入选标准
- •1.Children (any gender) aged 1 to < 5 years on day of enrollment.
- •2.History of received 1 dose of IMOJEV as primary JE vaccination at least 1 year to 2 years prior to enrollment for booster dose.
- •3.In good general health at enrollment.
- •4.Informed consent by parent(s) or legal guardian(s)
- •5.Able to follow up for 28-35 days after enrollment.
- •6.Has not been received any vaccine within 30 days before enrollment.
排除标准
- •1.Acute febrile illness on day of vaccination.
- •2.Had been received any JE vaccine before (except IMOJEV for 1 dose).
- •3.Receipt of blood or blood products in the past 3 months or plan to receive blood or 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 received any vaccine within 30 days prior study vaccine.
- •7.Planned to receive 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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