A Phase III, Randomized, Blinded, and Homologous Vaccine-Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Rabies Vaccine (Human Diploid Cell), Freeze-dried, Vaccinated With Different Immunization Schedules in a Population Aged 10 to 60 Years

Ab&B Bio-tech Co., Ltd.JS5 个研究点分布在 1 个国家目标入组 3,000 人开始时间: 2025年12月18日最近更新: 2025年12月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 3,000
试验地点: 5
主要终点: Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A total of 3,000 participants will be enrolled, stratified by age into two groups: 600 participants aged 10-17 years and 2,400 participants aged 18-60 years. Within each age group, participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five vaccination schedule groups: Essen Control Group (Group A), Essen Experimental Group (Group B), Zagreb Experimental Group (Group C), Simplified Four-Dose Group 1 (Group D), and Simplified Four-Dose Group 2 (Group E).

Among participants in the four experimental groups-Essen Experimental Group, Zagreb Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2-stratified block randomization will be applied. Within each age group and each vaccination schedule group, participants will be further randomized in a 1:1:1 ratio into three subgroups: those receiving a booster dose at Day 90 after completion of the primary immunization, those receiving a booster dose at Day 180, and those undergoing assessment of immune persistence at Day 360 after completion of the primary immunization.

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 between 10 and 60 years at the time of enrollment.
•The participant and/or their legal guardian voluntarily agrees to participate in the trial and signs the informed consent form.
•The participant and their family are able to comply with the trial follow-up schedule as required by the protocol (no plans for extended absence or relocation from the study site).
•Female participants are neither pregnant nor lactating (negative urine pregnancy test prior to vaccination), and have no plans to become pregnant within 2 months after enrollment.

排除标准

•a Exclusion criteria for the first dose:
•Axillary body temperature ≥37.3°C at screening.
•History of rabies vaccination or administration of rabies-specific passive immunization products, or history of bites/scratches by dogs or other mammals within the past year.
•History of severe allergic reactions requiring medical intervention to any vaccine or vaccine components, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, Arthus reaction, severe urticaria, or angioedema.
•Fever, acute or chronic infectious diseases (e.g., active tuberculosis, viral hepatitis), or acute exacerbation of chronic illness within 3 days before the first vaccine dose.
•Receipt of blood, blood products, or immunoglobulins within 3 months prior to the first vaccine dose, or planned use of such products within 1 month after the final vaccine dose.
•Receipt of any other vaccines within 14 days prior to the first vaccine dose.
•Asplenia or functional asplenia due to any condition (e.g., splenectomy).
•Diagnosed congenital or acquired immunodeficiency (including HIV infection), or treatment with immunosuppressive agents within the past 3 months (e.g., systemic corticosteroids for ≥14 days at doses ≥2 mg/kg/day or ≥20 mg/day of prednisone or equivalent).
•Presence of severe congenital malformations, autoimmune (hereditary) diseases, or severe chronic conditions (including but not limited to: thalassemia, heart disease, kidney disease, diabetes, hereditary allergic constitution, Guillain-Barré syndrome, etc.)
•Personal or family history of convulsions, epilepsy, encephalopathy, or psychiatric disorders.
•Contraindications to intramuscular injection (e.g., diagnosed thrombocytopenia, any coagulation disorder, or current use of anticoagulant therapy).
•Uncontrolled hypertension (e.g., systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at screening for adults aged 18 years and above).
•Currently participating in another clinical trial involving investigational or unregistered products (drugs or vaccines), or planning to participate in another clinical trial before completion of this study.
•Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
•b Exclusion criteria for subsequent doses:
•Positive urine pregnancy test；
•Severe anaphylaxis after the previous dose;
•Grade 4 adverse events associated with trial vaccination after the previous dose;
•Exposure during the course (bite or scratch from dogs, cats or other mammals);
•Participant has any other conditions that warrant discontinuation of vaccination as determined by the investigator.