NCT01949857已完成4 期
Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine
Institute of Medical Biology, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 35,000 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35,000
- 试验地点
- 1
- 主要终点
- changes of hepatitis A antibody concentration
研究概览
简要总结
The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.
详细描述
Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only subjects fulfilling all of the following criteria will be eligible for the study:
- •People aged from 18 months to 65 years old.
- •The subjects or subjects' guardians are able to understand and sign the informed consent
- •The subjects or subjects' guardians allow to comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
- •The subjects have signed informed consent already
排除标准
- •Subjects will not be eligible for the study if any of the following criteria is met:
- •Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
- •Have a history of neurological symptoms or signs
- •Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
- •Suffering from serious chronic diseases
- •Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
- •Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
- •Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
- •Any prior diseases including human immunodeficiency virus infection or related
- •Bleeding constitution or prolong bleeding time situation
- •Accept hepatitis A vaccination within a month
- •Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
- •People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
- •Caught a fever with axillary temperature 38°C or higher in past 3 days
- •Take part in another clinical researchers
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- •Pregnancy test result is positive
结局指标
主要结局
changes of hepatitis A antibody concentration
时间窗: up to 43 months
1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
次要结局
- The frequency of all the adverse events in vaccine group and placebo group(up to 43 months)
研究者
研究点 (1)
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