Observation of Immune Persistence in a Clinical Trial of an Adsorbed Tetanus Vaccine

September 2, 2026 updated by: CanSino Biologics Inc.

Observation of Immune Persistence in a Phase III Clinical Trial of an Adsorbed Tetanus Vaccine

This study included 240 trial participants who had previously taken part in a Phase III clinical trial of an adsorbed tetanus vaccine (Protocol No.: CTP-TTVA-001), with 120 participants in each of the treatment and control groups. All trial participants were required to provide 3.0-4.0 mL of blood for an immunodurability assessment 2.5 years after vaccination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

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 included 240 participants who had previously taken part in a Phase III clinical trial of the adsorbed tetanus vaccine (Protocol No.: CTP-TTVA-001), with 120 participants in each of the treatment and control groups.

Description

Inclusion Criteria:

  • Individuals who have previously participated in the Phase III clinical trial of the adsorbed tetanus vaccine (Protocol No.: CTP-TTVA-001).
  • Willing to provide identification documents.
  • Have given informed consent, voluntarily signed the informed consent form, and are able to comply with the requirements of the clinical trial protocol.
  • At least 2.5 years have elapsed since completion of the vaccination series.

Exclusion Criteria:

  • Following vaccination in the Phase III clinical trial (Protocol No.: CTP-TTVA-001), participants who have received tetanus immunoglobulin, tetanus antitoxin, or a vaccine containing tetanus toxoid antigen.
  • Participants in the previous Phase III clinical trial (Protocol No.: CTP-TTVA-001) who did not complete the blood draw 30 days after vaccination.
  • Other circumstances deemed by the investigator to render a participant ineligible for this clinical study.

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
Intervention / Treatment
Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA)
Other: Previously vaccinated with TTVA
3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.
Previously vaccinated with Tetanus Vaccine, Adsorbed (TT)
Other: Previously vaccinated with TT
3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positivity rate of IgG antibodies against tetanus toxoid.
Time Frame: 2.5 years after vaccination
2.5 years after vaccination
Geometric mean concentration (GMC) against tetanus toxoid.
Time Frame: 2.5 years after vaccination
2.5 years after vaccination
The proportion of antibody concentrations ≥ 1.0 IU/mL 2.5 years after vaccination.
Time Frame: 2.5 years after vaccination
2.5 years after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CanSino Biologics Inc.

Investigators

  • Principal Investigator: Qiuyue Mu, Guizhou Center for Disease Control and Prevention

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 (Estimated)

October 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-TTVA-002

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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