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DiphtheriaPhase 1NCT06056050

A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

A Phase 1 study testing Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp), 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23） and Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT) in people with Diphtheria and Tetanus, run by CanSino Biologics Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. 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?
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp), 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23） and Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
6 Dec 2023to 11 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • ≥ 6 years of age.
  • Willingness to provide proof of identity.
  • The informed consent of the volunteer and/or the guardian and/or the delegate must be obtained and the informed consent form must be signed.
  • Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up.
  • Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, but have not received the 5th dose, and have ≥3 years between the 4th dose.
  • Volunteers aged ≥12 years must not have received any of the components of the DPT-containing vaccine within 5 years.

Who cannot join

  • Persons with fever prior to vaccination, with axillary temperature > 37.0°C.
  • A female with a positive urine pregnancy test or a breastfeeding volunteer, where the volunteer or her partner has a plan to become pregnant within 180 days.
  • Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication, or other severe chronic diseases.
  • Abnormal and clinically significant results of preimmunization blood tests, blood biochemistry and urine tests.
  • Persons who have suffered from one of the diseases of diphtheria or tetanus, or who have suffered from whooping cough in the last three years.
  • Volunteers ≥12 years of age who have received pneumococcal polysaccharide/conjugate-containing vaccine within 4 years.
Show all 15Show fewer
  • Individuals who have had household contact with individuals diagnosed with pertussis, diphtheria, tetanus in the past 30 days.
  • Individuals who are allergic to the components of the study vaccine or who have developed an allergy during previous administration of the same vaccine; individuals with a previous history of severe allergies, such as urticaria, anaphylaxis, respiratory distress, angioneurotic edema, or asthma.
  • History of convulsions, epilepsy, encephalopathy and serious neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), etc.
  • Individuals with primary and secondary immune impairment (history of thyroid, pancreas, liver, spleen, kidney disease or removal, or need for treatment due to thyroid disease within the past 12 months), who have received immunosuppressive therapy within 3 months.
  • Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders.
  • Persons with acute febrile illnesses and current patients with infectious diseases who have had a history of moderately high fever (axillary temperature ≥38.0°C) or cardiopulmonary disease (frequent asthma attacks) within the past 3 days.
  • Has received another investigational drug or vaccine within 1 month prior to receiving the experimental drug, or is planning to participate or is participating in a clinical study of any other drug.
  • Received live attenuated vaccine within 14 days prior to receiving the test drug and subunit vaccine or inactivated vaccine within 7 days prior to receiving the test drug.
  • Any other factors that, in the judgment of the investigator, make the volunteer unsuitable for participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shaanxi Center for Disease Control and Prevention

    Xi'an, Shaanxi, 710054

Other trials in China

About this study

Official title: A Randomized, Blinded, Controlled Phase I Clinical Trial for Preliminary Evaluation of the Safety and Immunogenicity of Adsorbed Cell-free DPT Vaccine (for People Aged 6 Years and Above)

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.

Read the detailed description

The vaccines used in China's immunization program for the prevention of pertussis, tetanus and diphtheria include the adsorbed cell-free diphtheria-tetanus-acellular pertussis vaccine (DTaP) and the diphtheria-tetanus-acellular tetanus vaccine (DT) and tetanus vaccine. Among them, DTaP vaccination is for children from 3 months of age to 6 years of age, with one dose each at 3, 4, 5, and 18 months of age; DT vaccination is for children under 12 years of age, with one dose at 6 weeks of age after completing four doses of DTaP vaccination. However, infant and young child vaccination is no longer sufficient to prevent the threat of this disease, mainly due to the rapid decay of immune protection in adolescents and adults, and infections in this population, which are the main source of infection leading to infection in infants and young children, have been a number of new preventive strategies are being evaluated.

Being tested
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp), 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）, Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
Keywords
Vaccine, Five Components, Immunogenicity, Safety, ≥6 years, Acellular
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.

  • Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)Biological

    1 dose of Tdcp vaccine (0.5ml) on Day 0

  • 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）Biological

    1 dose of PPV23 vaccine (0.5ml) on Day 0

  • Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)Biological

    1 dose of DT vaccine (0.5ml) on Day 0

Study groups in NCT06056050
Study groupRoleWhat they receive
Experimental vaccine group 1A,≥18 years oldExperimental1 dose of Tdcp vaccine
Receives: Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
Control vaccine group 1B,≥18 years oldActive comparator1 dose of PPV23 vaccine
Receives: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）
Experimental vaccine group 2A,12~17 years oldExperimental1 dose of Tdcp vaccine
Receives: Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
Control vaccine group 2B,12~17 years oldActive comparator1 dose of PPV23 vaccine
Receives: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）
Experimental vaccine group 3A,6~11 years oldExperimental1 dose of Tdcp vaccine
Receives: Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp)
Control vaccine group 3B,6~11 years oldActive comparator1 dose of DT vaccine
Receives: Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse reactions 0-30 days after vaccination

    Measured: 0-30 days after vaccination

Secondary outcomes (16)

  1. Incidence of adverse reactions within 30 minutes of vaccination

    Measured: Within 30 minutes of vaccination

  2. Incidence of adverse reactions/adverse events 0-7 days after vaccination

    Measured: 0-7 days after vaccination

  3. Incidence of adverse events 0-30 days after vaccination

    Measured: 0-30 days after vaccination

  4. Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group

    Measured: 360 days after vaccination

  5. Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group

    Measured: 180 days after vaccination

  6. Hemoglobin content (HGB) on day 4 after vaccination

    Measured: Day 4 after vaccination

  7. White blood cell count on day 4 after vaccination

    Measured: Day 4 after vaccination

  8. Alanine aminotransferase (ALT) in blood on day 4 after vaccination

    Measured: Day 4 after vaccination

  9. Aspartate aminotransferase (AST) in blood on day 4 after vaccination

    Measured: Day 4 after vaccination

  10. Total bilirubin (TBIL) in blood on day 4 after vaccination

    Measured: Day 4 after vaccination

  11. Protein in urine on day 4 after vaccination

    Measured: Day 4 after vaccination

  12. Erythrocytes in urine on day 4 after vaccination

    Measured: Day 4 after vaccination

  13. Antibody Positive Turnover of Serum Anti-Diphtheria Toxoid(DT), Tetanus Toxoid(TT), Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), FIM bridal agglutinogens(FIM) 2&3 at 30 days after vaccination

    Measured: 30 days after vaccination

  14. Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination

    Measured: 30 days after vaccination

  15. Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination

    Measured: 30 days after vaccination

  16. Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination

    Measured: 30 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start6 Dec 2023
  3. Primary completion13 Apr 2024
  4. Study completion11 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056050
Sponsor's protocol ID
CTP-Tdcp-001
Status last verified
Aug 2026
First submitted
19 Sep 2023
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu X, Wei C, Huang H, Wan J, Li Y, Wang F, Li S, Wang Y, Wang X, Wang X, Sui X, Gou J, Zhu T, Ma X, Hu W. Preliminarily evaluation the safety and immunogenicity of tetanus, reduced diphtheria and acellular pertussis (five components) combined vaccine, adsorbed (Tdcp) in participants aged 6 years and above: a blinded and randomised, and controlled phase I clinical trial. Front Immunol. 2025 Sep 5;16:1616574. doi: 10.3389/fimmu.2025.1616574. eCollection 2025.

    PubMed 40977696

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp), 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23） and Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT) in people with Diphtheria and 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 7 Aug 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse reactions 0-30 days after vaccination (time frame: 0-30 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06056050, which also lists 1 linked publication.

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 7 Aug 2026.

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