> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-iii-clinical-trial-of-adsorbed-tetanus-vaccine-977bd5ff-fc89-41ff-bd1f-59ecbb3d9a84 > Record changed: 2026-10-13 # Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine NCT07740733 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Participants 1,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Lead sponsor Beijing Minhai Biotechnology Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Start date 2024-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Short title** Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Dates **Completion date** 2024-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **First posted** 2026-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Registry last updated** 2026-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Primary completion date** 2024-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Start date** 2024-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Size and sites **Actual participants** 1,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Participants** 1,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Lead sponsor** Beijing Minhai Biotechnology Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Identifiers **Registry ID** NCT07740733 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **ClinicalTrials.gov ID** NCT07740733 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Outcomes ### Primary outcomes 1. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 43 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy local residents aged 18-43 years; 2. Obtain informed consent from volunteers and have them sign the informed consent form. 3. Able to comply with the requirements of the clinical trial protocol; 4. Axillary temperature ≤37.0°C. ### Exclusion criteria 1. History of tetanus infection; 2. Receipt of tetanus vaccine or a vaccine containing tetanus toxoid antigen within 10 years, or tetanus immunoglobulin within 6 months; 3. Known allergy to vaccine components or history of severe post-vaccination allergy; 4. History of epilepsy, seizures, convulsion or family history of psychiatric illness; 5. Immunodeficiency, immunosuppressive / immunostimulatory therapy within 3 months (>14 days continuous oral/IV), or Immunocompromised individuals due to HIV; 6. Asplenia or functional splenic deficiency due to any cause; 7. Congenital anomalies, developmental disorders, or severe chronic diseases (e.g., Down syndrome, diabetes, sickle cell disease, neurological disorders, Guillain-Barré syndrome); 8. Known or suspected co-existing conditions include: severe respiratory, cardiovascular, hepatorenal diseases, uncontrolled hypertension on medication, malignancy, acute infections, or active chronic diseases; 9. Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders) or Coagulation disorder; 10. Blood product use within 3 months; 11. Token another investigational drug study within 1 month; 12. Live attenuated vaccine within 14 days; 13. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Sites - Guangdong Provincial Center for Diseases Control and PreventionGuangzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07740733) ## Related records ### Drugs (1) - [Tetanus toxoid](https://trialight.com/data/asset/tetanus-toxoid-dd6989f1-5729-447f-81e2-00892bc7a4f6.md) ### Lead sponsors (1) - [Beijing Minhai Biotechnology Co., Ltd](https://trialight.com/data/company/beijing-minhai-biotechnology-co-ltd-8d7415ad-fa7c-4aa4-ba92-8cbf7e1ca51c.md) ### Conditions (1) - [Tetanus](https://trialight.com/data/condition/tetanus-a589c209-81c5-56e6-8a55-6d96fedb2c61.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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