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

N/ANot Yet RecruitingNCT07807033

CanSino Biologics Inc.240 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

240

Conditions

Tetanus

Interventions

Previously vaccinated with TTVAOTHER

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

Previously vaccinated with TTOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Bijie, Guizhou, China

Outcomes

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

Central Contacts

Shunda Zhang

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.