An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 703
- 试验地点
- 2
- 主要终点
- Immunogenicity index-the seropositive rates of varicella antibody
研究概览
简要总结
This an open phase Ⅳ clinical trial of live attenuated varicella vaccines 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 5 and 8 years after primary immunization with live attenuated varicella vaccine.
详细描述
This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
- •The subject and/or guardian can understand and voluntarily sign the informed consent form;
- •Proven legal identity.
排除标准
- •History of chickenpox or shingles;
- •History of varicella vaccination since phase Ⅲ clinical trial;
- •Autoimmune disease or immunodeficiency / immunosuppression;
- •History of immunosuppressive therapy 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
349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.
干预措施: Investigational Live Attenuated Varicella Vaccine (Biological)
Control Group
354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.
干预措施: Placebo (Freeze Dired Dilution) (Biological)
结局指标
主要结局
Immunogenicity index-the seropositive rates of varicella antibody
时间窗: 8 years after primary immunization
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Immunogenicity index-seropositive rates of varicella antibody
时间窗: 5 years after primary immunization
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Immunogenicity index-the GMT of varicella antibody
时间窗: 8 years after primary immunization
GMT of varicella antibody in 8 years after primary immunization with varicella
Immunogenicity index-GMT of varicella antibody
时间窗: 5 years after primary immunization
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
次要结局
未报告次要终点