Status:
COMPLETED
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.
Conditions:
Tetanus
Eligibility:
All Genders
18-44 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the s...
Detailed Description
This is a randomized, double-blind, positive controlled design clinical trial of tetanus vaccine, adsorbed.The purpose of this study is to evaluate the safety and immunogenicity of tetanus vaccine, ad...
Eligibility Criteria
Inclusion
- Healthy aldults aged 18-44 months;
- Proven legal identity;
- Subjects have the ability to understand and agree to sign the informed consent form.
Exclusion
- 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 10 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the previous 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2024
Estimated Enrollment :
1260 Patients enrolled
Trial Details
Trial ID
NCT06049940
Start Date
September 1 2023
End Date
March 22 2024
Last Update
July 12 2024
Active Locations (1)
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1
Liangyuan District Center for Disease Control and Prevention
Shangqiu, Henan, China, 450016