Observation of Immune Persistence in a 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.

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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Disease Control and Prevention, Qixingguan District, Bijie City

Bijie, Guizhou, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Previously vaccinated with TTVA

Other

3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.

Previously vaccinated with TT

Other

3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.

Primary outcomes

Positivity rate of IgG antibodies against tetanus toxoid.

Time frame: 2.5 years after vaccination
Geometric mean concentration (GMC) against tetanus toxoid.

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shunda Zhang

CONTACT

[email protected]

022-58213600-6051

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Sep 8, 2026
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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