Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
Tetanus
About this trial
This is an interventional prevention trial for Tetanus
Eligibility Criteria
Inclusion Criteria: Healthy aldults aged 18-44 months; Proven legal identity; Subjects have the ability to understand and agree to sign the informed consent form. Exclusion Criteria: Armpit temperature of persons with fever on the day of experimental vaccine administration>37.0 ℃; Previous history of tetanus infection; Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DTP, meningococcal conjugate vaccine, etc.) within the last 5 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the last 6 months; Women who are lactating, pregnant (with a positive urine pregnancy test) or planning to become pregnant within the last 3 months; History of asthma, allergy to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, dyspnea, angioedema, or abdominal pain; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Have congenital or acquired immunodeficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA); Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc; Currently suffering from or have suffered from encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc.); A history of convulsions, epilepsy, psychosis or a family history of psychosis, and other serious neurological disorders; Diagnosed abnormal blood coagulation function (e.g. coagulation factor deficiency, coagulation disorders, abnormal platelets) or obvious bruising or coagulation disorders; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; A long history of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute onset of various acute diseases or chronic diseases in the last 7 days; Participating in clinical studies of other vaccines or drugs; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sites / Locations
- Liangyuan District Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental Group
Control Group
630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.
630 Participants (including 30 subjects in phaseⅠ, 600 subjects in phase Ⅲ ) will receive one dose of experimental vaccine or control vaccine.