Tetanus, Tetanus Vaccine
Conditions
Brief summary
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
Interventions
BIOLOGICALTetanus Toxoid (Adsorbed)
The study group's vaccines had been produced by Beijing Minhai Biotechnology Co., Ltd. Liquid formulation. 0.5 mL/vial.
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy local residents aged 18-43 years; 2. Obtain informed consent from volunteers and have them sign the informed consent form. 3. Able to comply with the requirements of the clinical trial protocol; 4. Axillary temperature ≤37.0°C.
Exclusion criteria
1. History of tetanus infection; 2. Receipt of tetanus vaccine or a vaccine containing tetanus toxoid antigen within 10 years, or tetanus immunoglobulin within 6 months; 3. Known allergy to vaccine components or history of severe post-vaccination allergy; 4. History of epilepsy, seizures, convulsion or family history of psychiatric illness; 5. Immunodeficiency, immunosuppressive / immunostimulatory therapy within 3 months (\>14 days continuous oral/IV), or Immunocompromised individuals due to HIV; 6. Asplenia or functional splenic deficiency due to any cause; 7. Congenital anomalies, developmental disorders, or severe chronic diseases (e.g., Down syndrome, diabetes, sickle cell disease, neurological disorders, Guillain-Barré syndrome); 8. Known or suspected co-existing conditions include: severe respiratory, cardiovascular, hepatorenal diseases, uncontrolled hypertension on medication, malignancy, acute infections, or active chronic diseases; 9. Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders) or Coagulation disorder; 10. Blood product use within 3 months; 11. Token another investigational drug study within 1 month; 12. Live attenuated vaccine within 14 days; 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tetanus antibody seroconversion rate at 30 days post-immunization. | From enrollment to completion of all follow-up visits, up to 180 days. |
Countries
China
Outcome results
None listed