Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
Completed · Phase 3
Conditions studied: Tetanus, Tetanus Vaccine
In brief
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
Key facts
- Study ID
- NCT07740733
- Run by
- Beijing Minhai Biotechnology Co., Ltd
- People needed
- 1240
- Starts
- 2024-02-29
- Expected to finish
- 2024-12-23
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 43. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Guangdong Provincial Center for Diseases Control and Prevention — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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