A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in… (NCT06123663) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over
China60 participantsStarted 2023-12-20
Plain-language summary
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.
Who can participate
Age range18 Years
SexALL
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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 …