Health TrialsbyHealthPanel

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

ConditionTetanus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCanSino Biologics Inc.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Previously vaccinated with TTVA

    Other intervention

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

  • Previously vaccinated with TT

    Other intervention

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA)1 intervention
Group B: Previously vaccinated with Tetanus Vaccine, Adsorbed (TT)1 intervention

Trial outcomes

Primary outcomes

1

Positivity rate of IgG antibodies against tetanus toxoid.

Time frame
2.5 years after vaccination
2

Geometric mean concentration (GMC) against tetanus toxoid.

Time frame
2.5 years after vaccination
3

The proportion of antibody concentrations ≥ 1.0 IU/mL 2.5 years after vaccination.

Time frame
2.5 years after vaccination

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CanSino Biologics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: