Can a single shot keep tetanus at bay?
NCT ID NCT06120751
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial is testing whether a single dose of an experimental tetanus vaccine is safe and triggers a protective immune response in adults aged 18 and older. Participants will receive either the new vaccine or a control vaccine, and researchers will measure antibody levels and monitor for side effects. The goal is to see if this vaccine could be a reliable way to prevent tetanus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental adsorbed tetanus vaccine (TTVA)
- What this could lead to
- If successful, this could provide a safe and effective option for protecting adults against tetanus, a serious bacterial infection.
- What could go wrong
- As with any vaccine, there is a risk of side effects, and the immune response may not be strong enough. This is a single trial, and results need confirmation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
1,000 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
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Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 informed consent form. * Ability to comply with the requirements of the clinical trial protocol and complete all follow-up studies. 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., HIV infection, history of thyroid, pancreas, liver, spleen, kidney disease or resection), immunosuppressive therapy, cytotoxic therapy, systemic glucocorticosteroid medication (≥14 days) within 6 months prior to enrollment (excluding spray corticosteroid 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 live attenuated vaccine 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Center for Disease Control and Prevention, Qixingguan District, Bijie City
Bijie, Guizhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tetanus immunity under the microscope: do antibodies hold up after 2.5 years?
- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- Can a Lab-Made antibody outperform standard tetanus shots?
- One shot, six protections: can a new vaccine match current standards?
- Can a new vaccine shield older kids and adults from three deadly infections?