Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 270
- 试验地点
- 4
- 主要终点
- Immunogenicity index-seropositive rates of neutralizing antibody
研究概览
简要总结
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.
详细描述
The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
- •Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- •Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.
排除标准
- •Had history of extra EV71 vaccination.
- •Previous history of hand-foot-mouth disease.
- •Participating in other research.
- •Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
- •Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
结局指标
主要结局
Immunogenicity index-seropositive rates of neutralizing antibody
时间窗: Year 13 after the second vaccination
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seropositive will be defined as the positive results with ties≥1:8
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
时间窗: Year 13 after the second vaccination
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
次要结局
未报告次要终点