Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
研究概览
简要总结
Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.
- •No Hepatitis A disease and contraindication of vaccination
- •No history of Hepatitis A Vaccine
- •The subjects can follow the requirements of experiment project.
- •Do not vaccinate other vaccine in one months.
- •Axillary's temperature≤37℃
排除标准
- •Having severe diseases.
- •Allergy to the components in Vaccine
- •Immune abnormalities
- •The people who do not agree with the Inclusion Criteria
- •Have a serious chronic disease
- •Any conditions which researcher think will influence the results or the subjects.
研究组 & 干预措施
Group 1
Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
干预措施: Hepatitis A Vaccine (Biological)
Group 2
Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited
干预措施: Hepatitis A Vaccine (Biological)
结局指标
主要结局
To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
时间窗: 35-42 days
Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 month)