NCT02288286已完成3 期
Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans From 10-60 Years Old
Beijing Center for Disease Control and Prevention0 个研究点目标入组 1,200 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 主要终点
- Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies vaccine (MRC-5 cells)in different age health human populations, according to the traditional Essen methods (1-1-1-1-1) vaccination.
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
- •10-60 years old healthy people with normal intelligence
- •Obtain informed consent from the participants or their guardians, and signed informed consent
- •The participants or their guardians can comply with the requirements of clinical trial scheme
- •The axillary temperature is 37.0 ℃ or less
排除标准
- •participants who vaccinated with rabies vaccine before
- •participants who used anti-rabies passive immunization agents
- •participants who were Suspect or have a history of injury which is hurted by warm-blooded mammals
- •Female who was pregnant, or in the lactation period, or have Pregnant plans in the clinical trial.
- •participants who have allergy history, especially those who are allergic to neomycin,or had serious adverse reactions ever, Such as allergies, hives, difficulty breathing, angioneurotic edema, or abdominal pain and so on.
- •participants who had been diagnosed or suspected to have immunodeficiency or Autoimmune diseases,or have Immune system disorders.
- •participants who have Thyroidectomy History,or had been treated because of Thyroid disease in the past year.
- •participants who had abnormal clotting which is diagnosed by doctor(such as clotting factor deficiency, coagulation disorders, platelet abnormalities),or who had coagulopathy.
- •Participants who had history of epilepsy, seizures or convulsions ,or family history of mental illness.
- •Participants who is asplenia, or functional asplenia, and asplenia or splenic resection under any circumstances.
- •Participants who had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids in the past six months. (It does not include Corticosteroid spray treatment Of allergic rhinitis, Surface treatment with corticosteroids because of acute uncomplicated dermatitis)
- •Participants who had Received blood products in the past 3 months
- •Participants who had Received other investigational drug in the past one month.
- •Participants who had received Live attenuated vaccine 14 days before the clinical trial.
- •Participants who had received Subunit vaccines and inactivated vaccines 7days before the clinical trial.
- •Participants who was having the prevent or the treatment of Antituberculosis.
- •Participants who had fever 3 days before receving the Vaccine.( Axillary temperature is above 38℃)
- •Participants who was suffering from severe chronic.( Such as Down's syndrome, diabetes, sickle cell anemia or neurological disorder, Guillain-Barre syndrome);
- •Participants who was diagnosed or suspected to be suffering from some disease, such as Respiratory diseases, acute infection, Chronic of active stage，Cardiovascular Disease, Severe hypertension, Skin disease ,or the mother or her children was HIV-infected, besides the participants were during the Treatment period of malignant tumors,.
- •According to the researchers, there are other factors that are not suitable for Participants to join the clinical trial.
结局指标
主要结局
Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
时间窗: within the first 4 weeks after the first vaccination
Adverse reactions associated with vaccine
次要结局
- Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans(within the first 4 weeks after the first vaccination)
研究者
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