NCT07724379

Brief Summary

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:

  1. 1.Analysis of tetanus antibody distribution across different age groups
  2. 2.Evaluation of the TQS method for determining antibody status
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,009

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 1, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Healthy AdultsVaccinationProtective EfficacyObservational StudyTQStetanus

Outcome Measures

Primary Outcomes (1)

  • Tetanus Antibody Level

    Single blood draw

    Baseline (single blood draw at enrollment)

Secondary Outcomes (1)

  • tetanus antibody level by TQS/mTQS method

    Baseline (single blood draw at enrollment)

Study Arms (5)

age group

20-29;30-39;40-49;50-59;≥60

gender group

male; female

education background

high school; bachelor; master; et al

primary vaccination

≥3 doses TTCV; \< 3 doses TTCV; unknown

last TTCV dose duration

≤5 year;5-10 year; \>10 year; unkown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Voluntarily sign the informed consent form;
  • Be aged 18 years or older;
  • Be willing to provide a blood sample for biochemical testing

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Department Director

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 24, 2026

Study Start

May 4, 2025

Primary Completion

March 3, 2026

Study Completion

May 15, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations