A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years

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.

Inclusion Criteria: * 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. Exclusion Criteria: 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.