An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
研究概览
简要总结
This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 ~71 months after full immunization of two doses of vaccine.
详细描述
This study is an open,observational and follow-up clinical trial of EV71 vaccine based on the clinical trial of EV71 vaccine extended age group.The main purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6~71 months after full immunization of two doses of vaccine.In this study, a total of 474 subjects from the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set，including 274 subjects aged 6~35 months (the maximum number of subjects aged 6-23 months is 146, and the maximum number of subjects aged 24-35 months is 128),100 subjects aged 36~71 months and were enrolled in experimental group(EV71 vaccine developed by Sinovac Biotech Co., Ltd) and 100 subjects aged 36~71 months and were enrolled in control group(EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences) will be enrolled .Blood samples will be collected from subjects aged 6-23 months at 36 months after full immunization and at the age of 72 months.Blood samples will be collected from subjects aged 24 to 35 months at 36 months after full immunization.Blood samples will be collected from subjects aged 36-71 months at 36 months after the full immunization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set;
- •Provide legal identification;
- •Participants or guardians of the participants should be capable of understanding the written consent form and voluntarily participate in the clinical trial.
排除标准
- •Vaccination history of vaccines containing EV71 antigen components other than the EV71 vaccine expanded age group clinical trial;
- •History of hand, foot and mouth disease caused EV71;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
时间窗: At 36 months after full immunization
The seroconversion rates (SCR) of EV71 neutralizing antibody of all subjects at 36 months after full immunization.
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months
时间窗: At the age of 72 months
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
GMT of the EV71 neutralizing antibody of all enrolled subjects
时间窗: At 36 months after full immunization
GMT of the EV71 neutralizing antibody of all enrolled subjects at 36 months after full immunization.
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months
时间窗: At the age of 72 months
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
次要结局
未报告次要终点