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

Inclusion criteria

• Age at enrollment ranged from 10 to 60 years；
• Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form;
• Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan)；
• Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment；
• The axillary temperature was < 37.3 ° C.

Exclusion criteria

a Exclusion criteria for the first dose:

• A history of rabies vaccine and specific passive immune preparation injection, and a history of dog or other mammal bite/scratch within the past 1 year;
• Those who are allergic to any component of the trial vaccine, or have had previous allergies to any component of the vaccine, or have had a history of severe allergies requiring medical intervention, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc;
• Fever (axillary temperature ≥37.3 ° C) within 3 days before the first dose of vaccination, acute or chronic infectious diseases (active tuberculosis, active viral hepatitis), or acute exacerbation of a chronic disease;
• Received blood/blood-related products or immune globulin within 3 months before the first dose of vaccine, or plan to use such a product after enrollment until 1 month after the last dose of vaccine;
• Vaccinate any vaccine within 14 days before the first dose of vaccine;
• Asplenia or functional asplenia due to any condition (e.g., splenectomy);
• Have been diagnosed with congenital or acquired immunodeficiency (HIV), or have been on immunosuppressive therapy within 3 months (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2mg/kg/ day or ≥20mg/ day of prednisone or prednisone equivalent);
• Severe congenital malformations or autoimmune (hereditary) diseases, severe chronic diseases (including but not limited to thalassemia, heart disease, kidney disease, diabetes mellitus, hereditary allergies, Guillain-Barre syndrome, etc.);
• People with a medical or family history of seizures, epilepsy, encephalopathy and psychosis;
• Contraindications to intramuscular injection (e.g. having been diagnosed with thrombocytopenia, any coagulopathy, or receiving anticoagulant therapy);
• Drug-uncontrolled hypertension, defined as pre-enrollment systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg (for adults aged 18 years and over);
• Are participating in other investigational or unregistered clinical studies of products (drugs or vaccines), or plan to participate in other clinical studies before the end of this clinical study;
• Patients with clinically significant abnormalities in laboratory tests such as blood routine, blood biochemistry, and urine routine could not be enrolled according to the comprehensive judgment of the investigators;
• The investigator considered the subject to have any condition that might interfere with the assessment of the purpose of the study.

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);
• Subject has any other conditions that warrant discontinuation of vaccination as determined by the investigator.