Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Antibody titer after 2 doses lived attenuated varicella vaccination
研究概览
简要总结
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.
详细描述
Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, 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 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 received other live attenuated vaccine vaccination in 30 days before enrollment;
- •Had been infected with Varicella virus and displayed symptom;
- •Have received one or two dose of Varicella vaccine before enrollment;
- •Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
- •Guillain-barre syndrome
- •Thyroid resection history or thyroid disease treatment in the past 12 months;
- •Have participated in other clinical research;
- •Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
结局指标
主要结局
Antibody titer after 2 doses lived attenuated varicella vaccination
时间窗: 1 year
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
次要结局
- Number of participants who have adverse reaction(1 year)