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

NCT07807033 | Not Yet Recruiting

• 1 other identifier: CTP-TTVA-002
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetanus

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Positivity rate of IgG antibodies against tetanus toxoid.

  2.5 years after vaccination

• 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

Study Arms (2)

Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA)

Other: Previously vaccinated with TTVA

Previously vaccinated with Tetanus Vaccine, Adsorbed (TT)

Other: Previously vaccinated with TT

Interventions

Previously vaccinated with TT OTHER

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

Previously vaccinated with Tetanus Vaccine, Adsorbed (TT)

Previously vaccinated with TTVA OTHER

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

Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

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

Bijie, Guizhou, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

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

Study Officials

• Qiuyue Mu

  Guizhou Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunda Zhang

CONTACT

022-58213600-6051; shunda.zhang@cansinotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-08

Locations

CN (1)