NCT07568522进行中（未招募）不适用
Extension Study of Protocol CT-EV-31s to Examine the Long-Term Immunogenicity After Receiving Inactivated EV71 Enterovirus Vaccine (Envacgen®) in Children
Medigen Vaccine Biologics Corp.4 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年11月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 4
研究概览
简要总结
This study is designed to evaluate the long-term antibody titers of Envacgen® approximately 6 years after the first vaccination dose in participants who were aged 2 months to <6 years at the time of enrollment in the CT-EV-31s study.
详细描述
This is an extension study of protocol CT-EV-31s, to evaluate the long-term immunogenicity of EV71 Enterovirus Vaccine (Envacgen®).
The study will consist of a single visit approximately 6 years after the first vaccination of the EV71 vaccine or Placebo in participants aged 2 months to < 6 years when participating in the CT-EV-31s study. Immunogenicity response against EV71 virus antigen at the visit will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who have completed participation in study CT-EV-31s and have received protocol specified doses of EV71 vaccine or Placebo.
- •The participant and/or participant's parent/guardian is able to understand and sign the informed consent form.
排除标准
- •The participant and/or participant's parent/guardian refuse to comply with the study procedures.
- •After completing the CT-EV-31s trial, participants who received any EV71 vaccine before participating in this study.
研究者
研究点 (4)
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