NCT01982409Unknown4 期
A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
Changchun Changsheng Life Science and Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2013年6月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
研究概览
简要总结
The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.
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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
- •Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Body temperature ≤37℃
排除标准
- •Participant with previous history of chickenpox or zoster
- •Receipt of varicella vaccine
- •Reported the family history of allergies, convulsions, epilepsy and mental illness
- •Known allergy to any constituent of the vaccine
- •Known serve illness, in a fever, acute infection and chronic disease activity
- •Receipt of steroid
- •Reported the history of thrombocytopenia or other coagulation disorders, which may cause
- •Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders)
- •Known dermatopathy with allergy, herpes, fester, and fungal infection
- •Receipt of whole blood, blood plasma or immunoglobulin in the 3 months preceding the trial vaccination
- •Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
- •Participant with fever(temperature≥ 38℃) in the days
- •Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
结局指标
主要结局
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
时间窗: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.
次要结局
- Breakthrough rate, duration and severity of varicella in vaccinated children(5 years period)
- Occurrence of adverse events(Up to 4 weeks after vaccination)
研究者
研究点 (1)
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