TetanusNCT07807033
Observation of Immune Persistence in a Clinical Trial of an Adsorbed Tetanus Vaccine
An observational study of Tetanus, run by CanSino Biologics Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Previously vaccinated with TTVA and Previously vaccinated with TT
- Type of treatment
- Vaccines
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 15 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Center for Disease Control and Prevention, Qixingguan District, Bijie City
Bijie, Guizhou
About this study
Official title: Observation of Immune Persistence in a Phase III Clinical Trial of an Adsorbed Tetanus Vaccine
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
- Being tested
- Previously vaccinated with TTVA, Previously vaccinated with TT
- Keywords
- Vaccine, ≥18years, Positive-controlled, Immune Persistence
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA) | Not described Receives: Other: Previously vaccinated with TTVA | |
| Previously vaccinated with Tetanus Vaccine, Adsorbed (TT) | Not described Receives: Other: Previously vaccinated with TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rate of IgG antibodies against tetanus toxoid.
Measured: 2.5 years after vaccination
Geometric mean concentration (GMC) against tetanus toxoid.
Measured: 2.5 years after vaccination
The proportion of antibody concentrations ≥ 1.0 IU/mL 2.5 years after vaccination.
Measured: 2.5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qiuyue Mu, Principal investigator, Guizhou Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807033
- Sponsor's protocol ID
- CTP-TTVA-002
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No