Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
试验速览
- 阶段
- 3 期
- 入组人数
- 317
- 主要终点
- The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)
研究概览
简要总结
This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.
详细描述
This clinical trial was designed as a multicenter, non-comparative, open-label clinical trial. This trial was conducted, written informed consent form by voluntary agreement, the subjects who have not had the hantavax vaccination history at the time of screening. Investigator product was administrated 0, 1, 2, 13 months.
For antibody test, Sampling was conducted pre-dose(T0), 28 days after the 2nd vaccination(before the 3rd vaccination, T1), 28 days after the 3rd vaccination(T2) and 11 months after the 3rd vaccination(before booster vaccination, T3), 28 days after the booster vaccination(T4), 2 months after the booster vaccination(T5) and 4 months after the booster vaccination(T6). Also, after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted, and the antibody test every year. In conclusion, sampling was conducted 12 months(T7), 24 months(T8), 36months(T9), 48 months(T10), 60 months(T11) after the booster vaccination.
However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ≥ 19years old.
- •Subjects who have not the hantavax vaccination history at the time of screening.
排除标准
- •Subject who did not passed by 2 weeks after recovering the acute disease.
- •immunologic dysfunction subjects.
- •Subjects previously treated with anti-coagulant therapy or hemophiliac patients.
- •Subjects with severe chronic diseases.
- •Subjects who had an acute before vaccinating IP.
- •Subjects who had received another vaccination during the 28 days before vaccinating IP or who were scheduled for another vaccination during the study.
- •Subjects who were receiving immunosuppressant or immune modifying drug
- •Subjects who had been administered immunoglobulins or blood-derived products 3 months before vaccinating IP or who were scheduled for the administration during the study.
- •Subjects of childbearing potential at the time of screening and were scheduled to pregnancy for the study. A female subject who was pregnant or who was breast-feeding
结局指标
主要结局
The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)
时间窗: 3 months
次要结局
- The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month)(3 months)
- The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month)(2 months)
- The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month)(14 months)
- The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 2 , 4, 12, 24, 36, 48, 60months after the 4th vaccination(13month)(15, 17, 25, 37, 49, 61, 73months)
- Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month)(15, 17, 25, 37, 49, 61, 73months)
- The Antibodies retention duration per the neutralizing antibody test(5 years)
- The Antibodies retention duration per the fluorescent antibody test(5 years)
- Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month)(2 months)
- Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month)(3 months)
- Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month)(14 months)