- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724379
A Study of Tetanus Antibody of Healthy Adults (tetanus)
July 20, 2026 updated by: Liu Si, Peking University First Hospital
A Prospective Study of Tetanus Antibody Protective Efficacy in Healthy Populations in Beijing
The goal of this observational study is to learn about antibody level of tetanus of adults in high-income city of china. The main question it aims to answer is:
- Analysis of tetanus antibody distribution across different age groups
- Evaluation of the TQS method for determining antibody status
- Correlation between primary vaccination history and tetanus antibody concentrations Blood samples were voluntarily provided by adult healthy participants for tetanus antibody analysis over a continuous collection period of more than one year.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2009
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100034
- Peking University First Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study will enroll healthy adults aged 18 years who reside in Beijing.
Participants will be recruited voluntarily from the general population.
Both males and females are eligible.
Participants must be willing to provide a blood sample and complete a brief questionnaire regarding their vaccination history.
Individuals with recent tetanus vaccination (within 5 years), acute illness, pregnancy, or immunosuppressive conditions will be excluded.
Description
Inclusion Criteria:
- Voluntarily sign the informed consent form;
- Be aged 18 years or older;
- Be willing to provide a blood sample for biochemical testing
Exclusion Criteria:
- Receipt of immunoglobulin, blood, or blood products within 6 months prior to enrollment;
- Refusal to provide tetanus vaccination history (including vaccination records, CDC vaccine administration registry, or subject's recall);
- Individuals with recent tetanus vaccination (within 5 years), acute illness, pregnancy, or immunosuppressive conditions will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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age group
20-29;30-39;40-49;50-59;≥60
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gender group
male; female
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education background
high school; bachelor; master; et al
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primary vaccination
≥3 doses TTCV; < 3 doses TTCV; unknown
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last TTCV dose duration
≤5 year;5-10 year; >10 year; unkown
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tetanus Antibody Level
Time Frame: Baseline (single blood draw at enrollment)
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Single blood draw
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Baseline (single blood draw at enrollment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tetanus antibody level by TQS/mTQS method
Time Frame: Baseline (single blood draw at enrollment)
|
at baseline
|
Baseline (single blood draw at enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2025
Primary Completion (Actual)
March 3, 2026
Study Completion (Actual)
May 15, 2026
Study Registration Dates
First Submitted
July 1, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 24, 2026
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024R524
- 2024IR10 (Other Grant/Funding Number: Peking University First Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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