Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT06120751
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and older, able to provide valid proof of identity for himself/herself.
* 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:
* Previously diagnosed tetanus infection.
* 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.
* Any circumstances that, in the judgment of the researcher, are likely to influence the assessment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06120751
Study Brief:
Protocol Section:
NCT06120751