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CompletedNCT07740733Updated Aug 3, 2026

Phase I/III Clinical Trial of Adsorbed Tetanus Vaccine

A Phase 3 interventional study of Tetanus Toxoid (Adsorbed) and Tetanus Toxoid (Adsorbed) in Tetanus and Tetanus Vaccine, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Feb 2024, registered Jul 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
1,240
Allocation
Randomized
Ages
18 Years to 43 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tetanus
  • Tetanus Vaccine

Browse trials for

03

In context

Tetanus

318 studies on the registry are indexed under Tetanus; 29 are open to participants now.

This study's enrollment of 1,240 is above the median of 418 across 280 interventional studies indexed under Tetanus.

Browse Tetanus studies →

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy local residents aged 18-43 years;
  2. Obtain 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

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, / immunostimulatory therapy within 3 months (>14 days continuous oral/IV), or Immunocompromised individuals due to ;
  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, , acute infections, or active chronic diseases;
  9. Clinically diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, disorders) or Coagulation disorder;
  10. Blood product use within 3 months;
  11. Token another drug study within 1 month;
  12. 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.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,240 participants (actual)

Study arms

  • Experimental
    study group

    620 participant

    Biological: Tetanus Toxoid (Adsorbed)

  • Active comparator
    control group

    620

    Biological: Tetanus Toxoid (Adsorbed)

Interventions

  • The study group's vaccines had been produced by Beijing Minhai Biotechnology Co., Ltd. Liquid formulation. 0.5 mL/vial.

  • The manufacture of control group vaccines were Chengdu Olymvax Biopharmaceuticals Inc. Liquid formulation. 0.5 mL/vial.

06

What researchers measure

Primary outcomes

  1. Tetanus antibody seroconversion rate at 30 days post-immunization.

    Time frame: From enrollment to completion of all follow-up visits, up to 180 days.

07

Study locations

1 site
  • Guangdong Provincial Center for Diseases Control and Prevention
    Guangzhou, Guangdong 510440, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07740733
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Feb 29, 2024
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024
Last update
Aug 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tetanus Toxoid

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