Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine

Inclusion criteria

• 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.

Exclusion criteria

• 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.