DiphtheriaNCT07744347
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
An observational study of Diphtheria and Tetanus, run by CanSino Biologics Inc..
Trial summary
This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Previously received the Tdcp vaccine at age 18 and older, Previously received the Tdcp vaccine at age 12-17 and Previously received the Tdcp vaccine at age 6-11
- Type of treatment
- Vaccines
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Oct 2033
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This clinical trial includes 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). For the immunopersistence study, approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination.
Who may be able to join
- Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
- Willingness to provide identification documents;
- Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
- The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.
Who cannot join
- Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
- Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
- Has a coagulation disorder;
- In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- Previously received the Tdcp vaccine at age 18 and older, Previously received the Tdcp vaccine at age 12-17, Previously received the Tdcp vaccine at age 6-11, Previously received the DT vaccine at age 6-11
- Keywords
- Vaccine, Five Components, ≥6 years, Immune Persistence
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously received the Tdcp vaccine at age 18 and olderOther
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the Tdcp vaccine at age 12-17Other
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the Tdcp vaccine at age 6-11Other
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the DT vaccine at age 6-11Other
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
| Study group | Role | What they receive |
|---|---|---|
| Previously received the Tdcp vaccine at age 18 and older | Not described Receives: Other: Previously received the Tdcp vaccine at age 18 and older | |
| Previously received the Tdcp vaccine at age 12-17 | Not described Receives: Other: Previously received the Tdcp vaccine at age 12-17 | |
| Previously received the Tdcp vaccine at age 6-11 | Not described Receives: Other: Previously received the Tdcp vaccine at age 6-11 | |
| Previously received the DT vaccine at age 6-11 | Not described Receives: Other: Previously received the DT vaccine at age 6-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Measured: 2.5, 5, and 10 years post-vaccination
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Measured: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
Measured: 2.5, 5, and 10 years post-vaccination
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
Measured: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL
Measured: 2.5, 5, and 10 years post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2033 (estimated)
- Study completion15 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Liu, Principal investigator, Center for Disease Prevention and Control, Shaanxi Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744347
- Sponsor's protocol ID
- CTP-Tdcp-005
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
- ClinicalTrials.gov ID
- NCT07744347
- Acronym / sponsor ID
- CTP-Tdcp-005
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- Vaccine, Five Components, ≥6 years, Immune Persistence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2033 (estimated)
- Study completion
- 15 Oct 2033 (estimated)
- First posted
- 4 Aug 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 clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Previously received the Tdcp vaccine at age 18 and older | – | Other: Previously received the Tdcp vaccine at age 18 and older |
| Previously received the Tdcp vaccine at age 12-17 | – | Other: Previously received the Tdcp vaccine at age 12-17 |
| Previously received the Tdcp vaccine at age 6-11 | – | Other: Previously received the Tdcp vaccine at age 6-11 |
| Previously received the DT vaccine at age 6-11 | – | Other: Previously received the DT vaccine at age 6-11 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This clinical trial includes 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). For the immunopersistence study, approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination.
Key inclusion criteria (4 listed)
- Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
- Willingness to provide identification documents;
- Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
- The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.
Key exclusion criteria (4 listed)
- Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
- Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
- Has a coagulation disorder;
- In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.
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 received the Tdcp vaccine at age 18 and olderApproximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence. | Other | Previously received the Tdcp vaccine at age 18 and older |
| Previously received the Tdcp vaccine at age 12-17Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence. | Other | Previously received the Tdcp vaccine at age 12-17 |
| Previously received the Tdcp vaccine at age 6-11Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence. | Other | Previously received the Tdcp vaccine at age 6-11 |
| Previously received the DT vaccine at age 6-11Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence. | Other | Previously received the DT vaccine at age 6-11 |
Primary outcome
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Time frame: 2.5, 5, and 10 years post-vaccination
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Time frame: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
Time frame: 2.5, 5, and 10 years post-vaccination
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
Time frame: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL
Time frame: 2.5, 5, and 10 years post-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 4 Aug 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.
Xiaoyu Liu principal investigator
Center for Disease Prevention and Control, Shaanxi Province
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria and Tetanus, run by CanSino Biologics Inc..
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 4 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ying Wang (022-58213600-6051, ying.wang@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 (time frame: 2.5, 5, and 10 years post-vaccination). The study lists 5 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 4 Aug 2026.