NCT07740733CompletedPhase 3
A Randomized, Blinded, Parallel-Controlled Phase I/III Clinical Trial to Evaluate the Safety and Immunogenicity of Adsorbed Tetanus Vaccine in Healthy Individuals Aged 18-43 Years
Beijing Minhai Biotechnology Co., Ltd1 site in 1 country1,240 target enrollmentStarted: February 29, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,240
- Locations
- 1
- Primary Endpoint
- Tetanus antibody seroconversion rate at 30 days post-immunization.
Study Overview
Brief Summary
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy local residents aged 18-43 years;
- •Obtain informed consent from volunteers and have them sign the informed consent form.
- •Able to comply with the requirements of the clinical trial protocol;
- •Axillary temperature ≤37.0°C.
Exclusion Criteria
- •History of tetanus infection;
- •Receipt of tetanus vaccine or a vaccine containing tetanus toxoid antigen within 10 years, or tetanus immunoglobulin within 6 months;
- •Known allergy to vaccine components or history of severe post-vaccination allergy;
- •History of epilepsy, seizures, convulsion or family history of psychiatric illness;
- •Immunodeficiency, immunosuppressive / immunostimulatory therapy within 3 months (>14 days continuous oral/IV), or Immunocompromised individuals due to HIV;
- •Asplenia or functional splenic deficiency due to any cause;
- •Congenital anomalies, developmental disorders, or severe chronic diseases (e.g., Down syndrome, diabetes, sickle cell disease, neurological disorders, Guillain-Barré syndrome);
- •Known or suspected co-existing conditions include: severe respiratory, cardiovascular, hepatorenal diseases, uncontrolled hypertension on medication, malignancy, acute infections, or active chronic diseases;
- •Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders) or Coagulation disorder;
- •Blood product use within 3 months;
- •Token another investigational drug study within 1 month;
- •Live attenuated vaccine within 14 days;
- •Subunit/inactivated vaccine within 7 days;
- •(13) Fever (≥38.0°C) or use of antipyretic/analgesic/anti-allergic drugs within 3 days; (14) Any other condition was deemed by the investigator to preclude trial participation.
Outcomes
Primary Outcomes
Tetanus antibody seroconversion rate at 30 days post-immunization.
Time Frame: From enrollment to completion of all follow-up visits, up to 180 days.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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