NCT07740733已完成3 期
A Randomized, Blinded, Parallel-Controlled Phase I/III Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Healthy Individuals Aged 18-43 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- Tetanus antibody seroconversion rate at 30 days post-immunization.
研究概览
简要总结
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
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
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy local residents aged 18-43 years;
- •Obtain informed consent from volunteers and have them sign the informed consent form.
- •Able to comply with the requirements of the clinical trial protocol;
- •Axillary temperature ≤37.0°C.
排除标准
- •History of tetanus infection;
- •Receipt of tetanus vaccine or a vaccine containing tetanus toxoid antigen within 10 years, or tetanus immunoglobulin within 6 months;
- •Known allergy to vaccine components or history of severe post-vaccination allergy;
- •History of epilepsy, seizures, convulsion or family history of psychiatric illness;
- •Immunodeficiency, immunosuppressive / immunostimulatory therapy within 3 months (>14 days continuous oral/IV), or Immunocompromised individuals due to HIV;
- •Asplenia or functional splenic deficiency due to any cause;
- •Congenital anomalies, developmental disorders, or severe chronic diseases (e.g., Down syndrome, diabetes, sickle cell disease, neurological disorders, Guillain-Barré syndrome);
- •Known or suspected co-existing conditions include: severe respiratory, cardiovascular, hepatorenal diseases, uncontrolled hypertension on medication, malignancy, acute infections, or active chronic diseases;
- •Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders) or Coagulation disorder;
- •Blood product use within 3 months;
- •Token another investigational drug study within 1 month;
- •Live attenuated vaccine within 14 days;
- •Subunit/inactivated vaccine within 7 days;
- •(13) Fever (≥38.0°C) or use of antipyretic/analgesic/anti-allergic drugs within 3 days; (14) Any other condition was deemed by the investigator to preclude trial participation.
结局指标
主要结局
Tetanus antibody seroconversion rate at 30 days post-immunization.
时间窗: From enrollment to completion of all follow-up visits, up to 180 days.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Phase I Clinical Trial of Adsorbed Tetanus VaccineTetanusNCT07598890Aimei Vacin BioPharm (Zhejiang) Co., Ltd.80
招募中
3 期
A clinical trial to evaluate the safety and immunogenicity of tetanus vaccine in healthy pregnant womenCTRI/2025/07/090196Human Biologicals Institute132
已完成
3 期
A Phase III Study to Evaluate the Immunogenicity and Safety of Typbar TCV Typhoid Vaccine in Adults greater than 65 Years.CTRI/2024/06/069638Bharat Biotech International Limited300
已完成
不适用
A Study of Tetanus Antibody of Healthy AdultsTetanusNCT07724379Peking University First Hospital2,009
Enrolling By Invitation
1 期
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-VaccinationNCT07330440Changchun BCHT Biotechnology Co.144