An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 6 and 10 Years After Booster Dose Immunization with Live Attenuated Varicella Vaccine
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Seropositive rate
研究概览
简要总结
This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.
详细描述
A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
- •The subjects and/or guardian can understand and voluntarily sign the informed consent form;
- •Proven legal identity.
排除标准
- •Beyond the blood collection window period;
- •History of varicella or shingles;
- •History of varicella vaccination since phase Ⅲ clinical trial;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
研究组 & 干预措施
Experimental Group
Subjects will be collected venous blood at 6 and 10 years after booster immunization.
干预措施: Live Attenuated Varicella Vaccine (Biological)
结局指标
主要结局
Seropositive rate
时间窗: at 10 years after booster vaccination
The seropositive rate of VZV antibodies at 10 years after booster vaccination
GMT of VZV antibody
时间窗: at 10 years after booster vaccination
The GMT of VZV antibodies at 10 years after booster vaccination
次要结局
未报告次要终点