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月最近更新:
适应症
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
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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