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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Immune Persistence in a Phase III Clinical Trial of an Adsorbed Tetanus Vaccine
- ClinicalTrials.gov ID
- NCT07807033
- Acronym / sponsor ID
- CTP-TTVA-002
- Conditions
- Tetanus
- Keywords
- Vaccine, ≥18years, Positive-controlled, Immune Persistence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA) | – | Other: Previously vaccinated with TTVA |
| Previously vaccinated with Tetanus Vaccine, Adsorbed (TT) | – | Other: Previously vaccinated with TT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previously vaccinated with TTVA3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study. | Other | Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA) |
| Previously vaccinated with TT3.0 to 4.0 mL of venous blood will be collected for the immunodynamic study. | Other | Previously vaccinated with Tetanus Vaccine, Adsorbed (TT) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiuyue Mu principal investigator
Guizhou Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetanus, run by CanSino Biologics Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shunda Zhang (022-58213600-6051, shunda.zhang@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity rate of IgG antibodies against tetanus toxoid. (time frame: 2.5 years after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.