NCT06056050

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2025

Completed
Last Updated

April 3, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

September 19, 2023

Last Update Submit

April 2, 2025

Conditions

DiphtheriaTetanusPertussis

Keywords

VaccineFive ComponentsImmunogenicitySafety≥6 yearsAcellular

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse reactions 0-30 days after vaccination

    0-30 days after vaccination

Secondary Outcomes (16)

  • Incidence of adverse reactions within 30 minutes of vaccination

    Within 30 minutes of vaccination

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

    0-7 days after vaccination

  • Incidence of adverse events 0-30 days after vaccination

    0-30 days after vaccination

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

    360 days after vaccination

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

    180 days after vaccination

  • +11 more secondary outcomes

Study Arms (6)

Experimental vaccine group 1A,≥18 years old

EXPERIMENTAL

1 dose of Tdcp vaccine

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

Control vaccine group 1B,≥18 years old

ACTIVE COMPARATOR

1 dose of PPV23 vaccine

Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）

Experimental vaccine group 2A,12~17 years old

EXPERIMENTAL

1 dose of Tdcp vaccine

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 old

ACTIVE COMPARATOR

1 dose of PPV23 vaccine

Biological: 23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）

Experimental vaccine group 3A,6~11 years old

EXPERIMENTAL

1 dose of Tdcp vaccine

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 old

ACTIVE COMPARATOR

1 dose of DT vaccine

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

Interventions

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

Experimental vaccine group 1A,≥18 years oldExperimental vaccine group 2A,12~17 years oldExperimental vaccine group 3A,6~11 years old
23-Valent Pneumococcal Polysaccharide Vaccine（PPV23）BIOLOGICAL

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

Control vaccine group 1B,≥18 years oldControl vaccine group 2B,12~17 years old
Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)BIOLOGICAL

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

Control vaccine group 3B,6~11 years old

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Center for Disease Control and Prevention

Xi'an, Shaanxi, 710054, China

Location

Related Publications (1)

  • 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.

    PMID: 40977696DERIVED

MeSH Terms

Conditions

DiphtheriaTetanusWhooping Cough

Interventions

Tetanus ToxoidVaccines, CombinedAging

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex MixturesGrowth and DevelopmentPhysiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 28, 2023

Study Start

December 6, 2023

Primary Completion

April 13, 2024

Study Completion

September 28, 2025

Last Updated

April 3, 2025

Record last verified: 2024-12

Locations

CN(1)