NCT02491541已完成3 期
A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years
Jiangsu Province Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2012年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
研究概览
简要总结
The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.
详细描述
There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 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
- •Aged from 10 to 60 years old
- •Subjects or legal guardians can and will comply with the requirements of the protocol
- •Subjects or legal guardians are able to understand and sign the informed consent
- •Healthy subjects judged from medical history after investigator's inquiry
- •Subjects with temperature <=37.0°C on axillary setting
排除标准
- •Female in lactation or pregnancy, or plan to be pregnant during the study period
- •Subject who has allergic history to any vaccine or other medicines
- •Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine
- •Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain
- •Subject with congenital malformation, developmental disorder or serious chronic disease
- •Subject with autoimmune diseases or immunodeficiency
- •Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids
- •Subject with diabetes (Type I or II) excluding gestational diabetes
- •Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease
- •Subject with severe angioedema in the past 3 years or require treatment in the past 2 years
- •Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time
- •Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder
- •Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period
- •Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years
- •Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
- •Guillain-Barre syndrome
- •Any prior administration of immunodepressant or corticosteroids in last 6 months
- •Any prior administration of blood products in last 3 months
- •Any prior administration of other research medicine/vaccine in last 30 days
- •Any prior administration of any attenuated live vaccine in last 30 days
- •Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- •Ongoing anti-tuberculosis prevention or treatment
- •Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years
- •Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
研究组 & 干预措施
Jilin Maifeng
Active Comparator
A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.
干预措施: Jilin Maifeng (Biological)
Changchun Werersai
Experimental
A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.
干预措施: Changchun Werersai (Biological)
结局指标
主要结局
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
时间窗: 42 days after full vaccination
次要结局
- Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination(42 days after full vaccination)
- Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination(14 days after full vaccination)
- Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination(14 days after full vaccination)
- Incidence of local and systemic adverse reactions during safety observation period after each vaccination(0-7 days after each vaccination and 8-28 days after the fifth vaccination)
研究者
研究点 (1)
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