Tetanus infection
Conditions
Interventions
Experimental group:Tetanus vaccine, Wuhan Institute of Biological Products, LLC
Control group:Tetanus vaccine from Chengdu OULIN Biotechnology Co., Ltd.
Sponsors
Guizhou Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=16 years on the day of enrollment and able to provide self verification of valid status; 2. Competent to understand study requirements and processes and agree to participate in clinical trials, with signed informed consent; 3. Competent to understand study procedures and be able to attend all planned follow-up visits; 4. Axillary temperature < 37.3 ° C on the day of enrollment; 5. Female non pregnant, non lactating; 6. Negative urine pregnancy test (for women of reproductive age); 7. Consent to take effective contraception during participation in the study and no pregnancy planning or birth planning (for volunteers of childbearing potential (females of reproductive age, men of school age) and for male volunteers whose partners are females of reproductive age).
Exclusion criteria
Exclusion criteria: 1. Have been diagnosed with tetanus infection in the past; 2. A previous severe allergic reaction to vaccination (e.g., acute anaphylaxis, urticaria, dyspnea, angioedema, or abdominal pain) or allergy to known components of tetanus vaccine; 3. Severe neurological disease (epilepsy, convulsions or convulsions) or psychosis or family history; 4. Persons with thrombocytopenia or other clotting disorders, or bleeding constitution or prolonged bleeding time, which may cause intramuscular injection contraindications; 5. Persons with known or suspected (or at high risk of developing) immune impairment or abnormalities, such as those who are or will be receiving immunosuppressive or immunoenhancement therapy, patients undergoing treatment for malignant tumors, human immunodeficiency virus infection or related diseases; 6. Severe liver and kidney diseases, medically uncontrollable hypertension (systolic blood pressure >=140mmHg, diastolic blood pressure >=90mmHg), diabetic complications, malignant tumors, acute or chronic diseases; 7. Congenital malformations, developmental disorders or serious chronic diseases (e.g., Down syndrome, diabetes mellitus, sickle cell anaemia or neurological disorders, Guillain-Barre syndrome); 8. Persons who have received tetanus vaccine or vaccines containing tetanus toxoid antigen (DPT vaccine, DPT vaccine, meningitis conjugate vaccine, etc.) within 10 years, or who have received tetanus immunoglobulin (including human or animal source), had blood transfusion or used blood products within the last 6 months; 9. Infected persons who have had any acute illness in the past 7 days that requires systemic antibiotic or antiviral treatment; 10. Those who have received another investigational drug or are participating in another clinical trial within 6 months prior to vaccination; 11. Any situation that the investigator considers likely to affect the evaluation of the trial; 12. Exclusion criteria for subsequent doses: (1) High fever (axillary temperature >=39.0?) and severe allergic reaction occurred within 48 hours after the previous dose of vaccine; (2) Serious adverse reactions causally related to the previous dose of vaccination; (3) Those newly discovered or newly occurring after the previous dose of vaccine do not meet the inclusion criteria of the first dose or meet the exclusion criteria of the first dose shall be determined by the researcher whether to continue to participate in the study; (4) Any other causes that the investigator assesses need to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events from 0 to 28/30 days;Tetanus antibody; | — |
Countries
China
Contacts
Public ContactGuan Qinghu
Guizhou Provincial Center for Disease Control and Prevention
Outcome results
None listed