Randomized, Double-blind, Controlled Phase Ⅰ and Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,260
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.
详细描述
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, adsorbed in 18~44 years old population.The study will conduct in two phases.A total of 1260 subjects including 60 subjects in phase Ⅰ and 1200 subjects in phase III will be enrolled.All of subjects in phase Ⅰ and phase III will be randomly assigned 2 groups in a 1:1 ratio to receive one dose of experimental vaccine or control vaccine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy aldults aged 18-44 months;
- •Proven legal identity;
- •Subjects have the ability to understand and agree to sign the informed consent form.
排除标准
- •Armpit temperature of persons with fever on the day of experimental vaccine administration>37.0 ℃;
- •Previous history of tetanus infection;
- •Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DTP, meningococcal conjugate vaccine, etc.) within the last 10 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the previous 6 months;
- •Women who are lactating, pregnant (with a positive urine pregnancy test) or planning to become pregnant within the last 3 months;
- •History of asthma, allergy to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Have congenital or acquired immunodeficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA);
- •Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
- •Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc;
- •Currently suffering from or have suffered from encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc.); A history of convulsions, epilepsy, psychosis or a family history of psychosis, and other serious neurological disorders;
- •Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency, coagulation disorders, abnormal platelets) or obvious bruising or coagulation disorders;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •A long history of alcohol or drug abuse;
- •Receipt of blood products within in the past 3 months;
- •Receipt of attenuated live vaccines in the past 14 days;
- •Receipt of inactivated or subunit vaccines in the past 7 days;
- •Acute onset of various acute diseases or chronic diseases in the last 7 days;
- •Participating in clinical studies of other vaccines or drugs;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
Incidence of adverse reactions
时间窗: within 30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination.
Incidence of local or systemic adverse reactions
时间窗: Within 7 days after vaccination
Incidence of local or systemic adverse reactions within 7 days after vaccination.
Incidence of SAE related to vaccination
时间窗: From the beginning of vaccination to 6 months after vaccination
Incidence of SAE related to vaccination from the beginning of vaccination to 6 months after vaccination.
Incidence of grade 3 and above adverse reactions
时间窗: Within 30 days after vaccination
Incidence of grade 3 and above adverse reactions within 30 days after vaccination
次要结局
- GMC increase folds (GMI) of anti-tetanus toxiod antibody(30 days after vaccination)
- Seroconversion rate of anti-tetanus toxiod antibody(30 days after vaccination)
- GMC of anti-tetanus toxiod antibody(30 days after vaccination)
- Long-term seroprotective rate of anti-tetanus toxiod antibody(30 days after vaccination)
- The seroprotective rate of anti-tetanus toxiod antibody(30 days after vaccination)