Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Advertise Events (AE) incidence within 1 month
研究概览
简要总结
To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
详细描述
- In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
- To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
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
- •People aged 10-60；
- •Body temperature on the day of enrollment<37.3℃ (axillary temperature)
排除标准
- •Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- •People with congenital or acquired immunodeficiency or other autoimmune diseases；
- •Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
结局指标
主要结局
Advertise Events (AE) incidence within 1 month
时间窗: 6 months
\- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Serious Adverse Events (SAE) incidence within 6 months
时间窗: 12 months
\- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Positive conversion rate of 14 days
时间窗: 6 months
\- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Antibody Geometric Mean Titer (GMT) of 14 days
时间窗: 6 months
\- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Positive conversion rate of 42 days
时间窗: 6 months
\- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
次要结局
- Antibody GMT of 42 days(6 months)
- Antibody test of 28 days(6 months)
- Antibody test within 12 months(18months)