NCT01821911已完成4 期
Phase 4 Study of Speeda® Rabies Vaccine for Human Use
Beijing Center for Disease Control and Prevention3 个研究点 分布在 1 个国家目标入组 10,500 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10,500
- 试验地点
- 3
- 主要终点
- Incidence Rate of Adverse Events of the rabies vaccine each injection
研究概览
简要总结
The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
详细描述
The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
- •Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- •Participant body temperature ≤ 37.0℃
- •Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)
排除标准
- •Three-level exposure
- •Known allergy to any constituent of the vaccine
- •Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- •Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Participation in any other interventional clinical trial
- •An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
- •Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
- •Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
- •Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
研究组 & 干预措施
Zagreb2-1-1
Experimental
Injection on day 0、7、21
干预措施: Zagreb2-1-1 (Biological)
Zagreb2-1-1
Experimental
Injection on day 0、7、21
干预措施: Essen (Biological)
Essen
Active Comparator
Injection on day 0、3、7、14、28
干预措施: Zagreb2-1-1 (Biological)
Essen
Active Comparator
Injection on day 0、3、7、14、28
干预措施: Essen (Biological)
结局指标
主要结局
Incidence Rate of Adverse Events of the rabies vaccine each injection
时间窗: 2 years
次要结局
- Antibody titre of the subject on 0、7、14、42、180、365(3 years)
研究者
研究点 (3)
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