A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over
NCT ID: NCT06123663
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2023-12-20
2024-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Tetanus Vaccine, Adsorbed (TTVA)
1 dose of (TTVA) (0.5ml)
TTVA
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
Tetanus Vaccine, Adsorbed (TT)
1 dose of (TT) (0.5ml)
TT
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
Interventions
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TTVA
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
TT
Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0
Eligibility Criteria
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Inclusion Criteria
* Ability to understand the requirements and process of the study and to agree to participate in the clinical trial and to sign an informed consent form.
* Ability to comply with the requirements of the clinical trial protocol and complete all follow-up studies.
Exclusion Criteria
* Vaccination against tetanus or vaccines containing tetanus toxoid antigen components (e.g., DPT, DPT, RCV, etc.) within 5 years.
* Axillary temperature \>37.0°C on the day of enrollment.
* Women with a positive urine pregnancy test or during pregnancy or breastfeeding.
* Women of childbearing age, male volunteers and male volunteers whose partner is a woman of childbearing age have a pregnancy plan or birth plan during the study period.
* Persons suffering from thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy that may contraindicate intramuscular injection.
* Suffering from serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, serious infectious or allergic skin diseases, hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), and being in the period of acute disease or chronic disease activity within 7 days.
* History of severe neurological disorders such as epilepsy, convulsions, encephalopathy, or history of psychiatric disorders.
* Previous history of severe allergy to vaccination or medication (anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), etc.).
* Allergy to certain components of the vaccine used in this clinical trial (mainly tetanus toxoid, aluminum hydroxide, sodium chloride, etc.) or allergy to the above components from previous vaccination.
* Known or suspected immunological abnormalities (e.g., HIV infection, history of thyroid, pancreas, liver, spleen, kidney disease or resection), immunosuppressive therapy, cytotoxic therapy, systemic glucocorticosteroid medication (≥14 days) within 6 months prior to enrollment (excluding spray corticosteroid therapy for allergic rhinitis, surface corticosteroid therapy for acute uncomplicated dermatitis, etc.) topical medications).
* Received blood products (whole blood, component blood, immune globulin, etc.) in the previous 3 months or plan to use such products within 1 month of vaccination.
* Vaccination with live attenuated vaccine within 14 days, subunit vaccine or inactivated vaccine within 7 days.
* Plans to participate or is participating in clinical studies of any other drug.
* Abnormalities in preimmunization blood counts and blood biochemistry that are judged by the investigator to be clinically significant.
* Any circumstances that, in the judgment of the researcher, are likely to influence the assessment.
18 Years
ALL
Yes
Sponsors
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CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shiguang Lei
Role: PRINCIPAL_INVESTIGATOR
Guizhou Center for Disease Control and Prevention
Locations
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Center for Disease Control and Prevention, Qixingguan District, Bijie City
Bijie, Guizhou, China
Countries
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Other Identifiers
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CTP-TTVA-001
Identifier Type: -
Identifier Source: org_study_id