TetanusPhase 3NCT07740733
Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine
A Phase 3 study testing Tetanus Toxoid (Adsorbed) in people with Tetanus and Tetanus Vaccine, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Tetanus Vaccine
- What is being tested?
- Tetanus Toxoid (Adsorbed)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 23 Dec 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Center for Diseases Control and Prevention
Guangzhou, Guangdong, 510440
About this study
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
The study aimed to evaluate the safety and immunogenicity of an adsorbed tetanus vaccine in healthy individuals between 18 and 43 years of age.
- Conditions
- Tetanus, Tetanus Vaccine
- Being tested
- Tetanus Toxoid (Adsorbed)
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Toxoid (Adsorbed)Biological
The study group's vaccines had been produced by Beijing Minhai Biotechnology Co., Ltd. Liquid formulation. 0.5 mL/vial.
Tetanus Toxoid (Adsorbed)Biological
The manufacture of control group vaccines were Chengdu Olymvax Biopharmaceuticals Inc. Liquid formulation. 0.5 mL/vial.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 620 participant Receives: Biological: Tetanus Toxoid (Adsorbed) |
| control group | Active comparator | 620 Receives: Biological: Tetanus Toxoid (Adsorbed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetanus antibody seroconversion rate at 30 days post-immunization.
Measured: From enrollment to completion of all follow-up visits, up to 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start29 Feb 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740733
- Sponsor's protocol ID
- 2023LP00599
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided