Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen

Exclusion Criteria

• •1. Fever on vaccination day, with axillary temperature \>37.0°C (aged ≥5years old) or \>37.3°C (aged 1\~4 years old) pre-vaccination;
• •2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
• •3. Previous administration with rabies immunoglobulins or monoclonal antibodies;
• •4. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
• •5. Female participants who are currently lactating or pregnant;
• •6. Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;
• •7. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
• •8. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
• •9. With poor controlled chronic illnesses or history of severe diseases, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, a history of major organ transplantation, drug-uncontrolled hypertension (only for participants aged ≥18 years old: with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), or any other disease or medical condition that the investigator believes could interfere with the trial results;
• •10. With current or past history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding history of febrile seizures\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
• •11. With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
• •12. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment in this study;
• •13. With long-term alcohol abuse \[\>14 drinks per week (1 drink =14 g 100% alcohol =360 mL beer, or 150 mL wine, or 45 mL distilled liquor/liquor)\] or substance abuse (repeated and heavy use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.)
• •14. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;
• •15. Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
• •16. Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;
• •17. Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
• •18. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended vaccination site that may interfere with drug administration or observation of local reactions;
• •19. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
• •20. Any other factors considered by the investigator to make the participant unsuitable for participation in the study