Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Antibody positive conversion rate of 4 doses groups
研究概览
简要总结
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
详细描述
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.
To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
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, Investigator)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age is 10-60 years old;
- •Underarm temperature ≤ 37.0 ℃.
排除标准
- •Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- •Has been diagnosed with congenital or acquired immunodeficiency disease；
- •Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
结局指标
主要结局
Antibody positive conversion rate of 4 doses groups
时间窗: 3 months
-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.
Safety within 0-7 days
时间窗: 3 months
\- Incidence rate of collected AE within 0-7 days after each dose of inoculation;
Safety within 6 months
时间窗: 9months
\- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.
Antibody positive conversion rate of experimental groups
时间窗: 3 months
\- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.
Compare the GMT between two experimental groups
时间窗: 3 months
\- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.
Geometric Mean Titer (GMT) of 4 doses groups
时间窗: 3 months
\- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.
Safety within 30 minutes
时间窗: 3 months
\- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;
次要结局
- Antibody test of 7 days.(3 months)
- Antibody test after whole vaccination.(3 months)
- Persistent observation within 12 months(16 months)