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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07807033

Enrollment

240

Registered

2026-09-08

Start date

2026-10-15

Completion date

2026-11-15

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetanus

Keywords

Vaccine, ≥18years, Positive-controlled, Immune Persistence

Brief summary

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.

Interventions

OTHERPreviously vaccinated with TTVA

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

OTHERPreviously vaccinated with TT

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Contacts

CONTACTShunda Zhang

shunda.zhang@cansinotech.com022-58213600-6051

PRINCIPAL_INVESTIGATORQiuyue Mu

Guizhou Center for Disease Control and Prevention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026