Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Incidence of varicella after 2 dose vaccination
研究概览
简要总结
To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.
详细描述
"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population.
Make the basic evaluation of safety for the two dose of varicella vaccination
Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district
Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants were between 4-12 years old
- •Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor
排除标准
- •Having a fever (axillary temperature >37.0℃) before enrollment;
- •Having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions;
- •Antibiotics allergy;
- •Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
- •Having immunodeficiency or under immunosuppression therapy, radiation therapy;
- •Having respiratory diseases, acute infection, chronic disease and HIV infection;
- •Having systemic skin rash, skin tinea, herpes;
- •Chronic liver and kidney disease;
- •Heart disease, and severe hypertension;
- •Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
- •Have not received other vaccination in 7 days before enrollment
结局指标
主要结局
Incidence of varicella after 2 dose vaccination
时间窗: 5 years
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
次要结局
- Adverse event rate of varicella vaccine after 2 dose injection(5 years)