The Immunogenicity and Safety of Different Vaccination Interval of Inactivated Hepatitis A Vaccine in People Aged 18-50 Years, a Phase IV Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,092
- 试验地点
- 1
- 主要终点
- The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month
研究概览
简要总结
This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-50;
- •Adults can understand and sign the informed consent form voluntarily;
- •Adults can provide valid and legal identity certificate.
排除标准
- •A history of hepatitis A infection;
- •Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine;
- •Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.);
- •Pregnant women and lactating women;
- •People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.);
- •Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases;
- •Received other research drugs within 30 days before vaccination with the experimental vaccine;
- •Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine;
- •Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine;
- •Other conditions that are not suitable for vaccination judged by the researcher.
结局指标
主要结局
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month
时间窗: 28 days after two dose of vaccination of hepatitis A vaccine
Incidence of adverse reaction within 28 days after one dose of vaccination
时间窗: 28 days after one dose of vaccination
次要结局
- The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months(28th day after two dose of vaccination)
- The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months(28 days after one dose of vaccination)
- Incidence of adverse reaction within 28 days after two dose of vaccination(28 days after two dose of vaccination)
- The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions(28 days after two dose of vaccination)
- Incidence of adverse reaction within 7 days after one dose of vaccination(7 days after one dose of vaccination)
- Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people(28 days after one dose of vaccination among)
- The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months(28 days after two dose of vaccination)
- The seropositive rate of anti-HAV antibody before vaccination(before vaccination)