Previously vaccinated with TTVAPreviously vaccinated with TT
Previously vaccinated with TTVA: 3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.
Previously vaccinated with TT: 3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Center for Disease Control and Prevention, Qixingguan District, Bijie City
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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