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CompletedNCT06120751Updated Aug 5, 2026

A Clinical Trial to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over

A Phase 3 interventional study of TTVA and TT in Tetanus, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by CanSino Biologics Inc. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups, Subjects who gave informed consent and passed the questioning screen were randomly assigned 1:1 to be immunized with 1 dose of Tetanus Vaccine, Adsorbed (TTVA) or control vaccine.

Read the detailed description

Tetanus can be prevented with tetanus toxoid-containing vaccines (TT-containing vaccines, TTCVs), which are included globally in routine immunization programs for children, and in many countries at the time of prenatal care. China eliminated neonatal tetanus in 2012, but non-neonatal tetanus remains a serious public health problem. TT vaccine was first produced in 1924 and is used as a single antigen vaccine and combination vaccine component to prevent other vaccine-preventable diseases, including diphtheria, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b (Hib), and other vaccine-preventable diseases. Haemophilus influenzae type b (Hib).

02

Conditions studied

  • Tetanus

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Keywords

  • Vaccine
  • Immunogenicity
  • Safety
  • ≥18 years
  • Positive-controlled
03

In context

Tetanus

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

This study's enrollment of 1,000 is above the median of 418 across 280 interventional studies indexed under Tetanus.

Browse Tetanus studies →

Lead sponsor

CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Browse CanSino Biologics Inc. studies →

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

04

Who can participate

Ages eligible
18 Years and older
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

  • 18 years of age and older, able to provide valid proof of identity for himself/herself.
  • Ability to understand the requirements and process of the study and to agree to participate in the clinical trial and to sign an form.
  • Ability to comply with the requirements of the clinical trial protocol and complete all follow-up studies.

Exclusion criteria

Exclusion Criteria:

  • Previously diagnosed tetanus infection.
  • Vaccination against tetanus or vaccines containing tetanus toxoid antigen components (e.g., DPT, DPT, RCV, etc.) within 5 years.
  • Axillary temperature >37.0°C on the day of enrollment.
  • Women with a positive urine pregnancy test or during pregnancy or breastfeeding.
  • Women of childbearing age, male volunteers and male volunteers whose partner is a woman of childbearing age have a pregnancy plan or birth plan during the study period.
  • Persons suffering from thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy that may contraindicate intramuscular injection.
  • Suffering from serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, serious infectious or allergic skin diseases, hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), and being in the period of acute disease or chronic disease activity within 7 days.
  • History of severe neurological disorders such as epilepsy, convulsions, encephalopathy, or history of psychiatric disorders.
  • Previous history of severe allergy to vaccination or medication (anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), etc.).
  • Allergy to certain components of the vaccine used in this clinical trial (mainly tetanus toxoid, aluminum hydroxide, sodium chloride, etc.) or allergy to the above components from previous vaccination.
  • Known or suspected immunological abnormalities (e.g., infection, history of thyroid, pancreas, liver, spleen, kidney disease or resection), therapy, cytotoxic therapy, systemic glucocorticosteroid medication (≥14 days) within 6 months prior to enrollment (excluding spray therapy for allergic rhinitis, surface corticosteroid therapy for acute uncomplicated dermatitis, etc.) topical medications).
  • Received blood products (whole blood, component blood, immune globulin, etc.) in the previous 3 months or plan to use such products within 1 month of vaccination.
  • Vaccination with within 14 days, subunit vaccine or inactivated vaccine within 7 days.
  • Plans to participate or is participating in clinical studies of any other drug.
  • Any circumstances that, in the judgment of the researcher, are likely to influence the assessment.
Terms in these criteria, in plain language(5)

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.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (actual)

Study arms

  • Experimental
    Tetanus Vaccine, Adsorbed (TTVA)

    1 dose of (TTVA) (0.5ml)

    Biological: TTVA

  • Active comparator
    Tetanus Vaccine, Adsorbed (TT)

    1 dose of (TT) (0.5ml)

    Biological: TT

Interventions

  • BiologicalTTVA

    Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0

  • BiologicalTT

    Intramuscular injection, 1 dose of 0.5ml inoculated on Day 0

06

What researchers measure

Primary outcomes

  1. Positive serum conversions of anti-tetanus toxoid IgG antibodies.

    Time frame: 30 days after immunization

  2. Incidence of adverse reactions (AR).

    Time frame: 0-30 days after immunization

Secondary outcomes

  1. Geometric mean multiplicity of increase (GMI) of anti-tetanus toxoid IgG antibodies in serum.

    Time frame: 30 days after immunization

  2. Positivity rate of anti-tetanus toxoid IgG antibodies in serum.

    Time frame: 30 days after immunization

  3. Geometric mean concentration (GMC) of anti-tetanus toxoid IgG antibodies in serum.

    Time frame: 30 days after immunization

  4. Proportion of serum with anti-tetanus toxoid IgG antibody concentration ≥1.0 IU/ml

    Time frame: 30 days after immunization

  5. Incidence of AR.

    Time frame: 30 minutes after immunization

  6. Incidence of adverse events (AE).

    Time frame: 0-30 days after immunization

  7. Incidence of AE/AR.

    Time frame: 0-7 days post-immunization

  8. Incidence of serious adverse events (SAEs).

    Time frame: 6 months post-immunization

07

Study locations

1 site
  • Center for Disease Control and Prevention, Qixingguan District, Bijie City
    Bijie, Guizhou, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Apr 2024, 1 month.

Of 54 industry-sponsored phase 3 interventional studies under Tetanus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 1 month is below that.

Counting every sponsor, half of 55 studies reached it within 12 months; a quarter within 6 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2023
First posted
Nov 7, 2023
StartActual
Mar 20, 2024
Primary completionActual
Apr 30, 2024
CompletionActual
Sep 30, 2024
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06120751
Lead sponsor
CanSino Biologics Inc.
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Mar 20, 2024
Primary completion
Apr 30, 2024
Completion
Sep 30, 2024
Last update
Aug 5, 2026

Study contacts

Shiguang Lei
principal investigator · Guizhou Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
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 Nov 2024. You cannot join it, but the record below documents what was studied.

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