Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
NCT07740733
Phase
Phase 3
Recruitment status
Completed
Participants
1,240
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Start date
2024-02-29
Number of sites
- 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.
- Short title
- Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-12-23
- First posted
- 2026-08-03
- Registry last updated
- 2026-08-03
- Primary completion date
- 2024-12-23
- Start date
- 2024-02-29
- Actual participants
- 1,240
- Participants
- 1,240
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07740733
- ClinicalTrials.gov ID
- NCT07740733
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
Tetanus antibody seroconversion rate at 30 days post-immunization.
Timeframe: From enrollment to completion of all follow-up visits, up to 180 days.
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 43 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- Guangdong Provincial Center for Diseases Control and PreventionGuangzhou, China
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Tetanus Primary condition