An Open-labelled Clinical Trial,to Evaluate the Immunity Persistence of the Single-dose Primary Immunization of Live Attenuated Varicella Vaccine on Different Time Points,and the Safety and Immunogenicity After the Booster Immunization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,193
- 试验地点
- 1
- 主要终点
- Immunogenicity index-seropositivity rate of antibody
研究概览
简要总结
This is an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization
详细描述
This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
- •Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
排除标准
- •Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency clinical trial;
- •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
Immunogenicity index-seropositivity rate of antibody
时间窗: 30 days after booster immunization
Seropositivity rate of antibody 30 days after booster immunization
Immunogenicity index-seroconversion rate of antibody
时间窗: 3 years after primary immunization
seroconversion rates of antibody 3 years after primary immunization
Immunogenicity index-Seroconversion rate of antibody
时间窗: 30 days after booster immunization
Seroconversion rate of the neutralizing antibody 30 days after booster immunization
次要结局
- Immunogenicity index-GMT of the antibody(Before the booster dose immunization)
- Immunogenicity index- GMT of the antibody(30 days after booster immunization)
- Immunogenicity index-Seropositivity rate of antibody(Before the booster dose immunization)
- Immunogenicity index- GMI of the antibody(30 days after booster immunization)
- Safety index-Incidence of SAE(within 30 days after vaccination)
- Safety index-Incidence of solicited local or systemic AE(within 14 days after vaccination)
- Safety index-Incidence of local or systemic AE(within 30 days after vaccination)