Tetanus
Conditions
Interventions
Observation group:None
Sponsors
People's hospital of yuxi
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old and <= 65 years old; 2.Mild trauma patients with wounds that penetrate the skin or mucosa caused by various reasons (animal injuries, burns, traffic accidents, etc.) at the time of screening, with the trauma occurring within 24 hours; 3.Patients who, as assessed by clinical doctors with reference to the "Diagnostic and Therapeutic Guidelines for Non-neonatal Tetanus (2024 Edition)", are deemed suitable for and are intended to receive equine-derived tetanus passive immunization preparation to prevent tetanus infection; 4. Research participants must give informed consent to this trial before the trial, fully understand the content, process, and possible adverse reactions of the trial, and voluntarily sign a written informed consent form; The process of obtaining informed consent is in accordance with GCP regulations;
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed with tetanus infection; 2. Individuals with a positive skin test result for equine tetanus immunoglobulin F(ab')2/tetanus antitoxin, either in the past or currently known; 3. Individuals for whom the estimated dosage of equine tetanus immunoglobulin F(ab')2 exceeds 1500 IU (one vial); 4. Individuals with a self-reported known or suspected history of systemic allergic reactions to the investigational drug and/or other equine-derived biological products (such as tetanus antitoxin, rabies antiserum, antivenom, etc.), or a history of allergic reactions to blood products; 5. Individuals with a significant history of drug, food, or protein allergies, or a personal or family history of bronchial asthma, hay fever, eczema, or angioneurotic edema; 6. Individuals who have had a fever (body temperature >= 38.0°C) within 3 days prior to medication administration; 7. Patients with hemorrhagic factors or at high risk of bleeding, including congenital bleeding disorders (such as hemophilia) or any clinically significant active bleeding, or platelet dysfunction; 8. Individuals with a history of epilepsy, convulsions, or seizures, or a family history of psychiatric disorders; 9. Individuals with confirmed or suspected immunodeficiency or autoimmune diseases; 1.those undergoing immunosuppressive therapy, such as anticancer chemotherapy or radiotherapy within the past 6 months, or long-term systemic corticosteroid treatment; 10. Individuals who have received live virus vaccines, such as measles, mumps, polio, or herpes vaccines, within the past 3 months; 11. Individuals currently engaging in alcohol abuse or drug abuse; 12. Individuals with known or suspected diseases that, in the investigator's judgment, may affect trial evaluation, such as severe respiratory diseases, acute infections or active phases of chronic diseases, severe cardiovascular diseases, liver or kidney diseases, or malignancies; 13. Patients currently participating in other clinical studies; 14. The patient is a member of the research center or his or her relatives or an employee directly involved in the conduct of this clinical study, or a person directly or indirectly related to the investigator; 15. Study participants with poor expected compliance by the investigator, or other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of local and systemic adverse events, as well as treatment-related adverse events (TRAEs), within 21 days after medication administration.; | — |
Countries
China
Contacts
Public ContactZhang Chen
People's hospital of yuxi
Outcome results
None listed