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A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)

NCT06708286•CanSino Biologics Inc.

View on ClinicalTrials.gov

Summary

This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Phase II : People ≥ 7 years old
•Phase II : Willing to provide identification documents
•Phase II : Volunteers must obtain informed consent from the volunteers themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
•Phase II : Volunteers aged 7\~11 years have completed 4 doses of vaccine containing DPT
•Phase II : ≥12 years old volunteers need to have not received any component vaccine containing DPT within 5 years
•Phase III : People ≥6 years old
•Phase III : Willing to provide identification documents
•Phase III : Volunteers must obtain informed consent from themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
•Phase III : Volunteers aged 6\~11 years old have completed 4 doses of DPT-containing vaccine in the past
•Phase III : Volunteers aged ≥12 years should not have received any vaccine containing any component of DPT within 5 years

Exclusion Criteria

•Those who have fever before vaccination, with axillary temperature \>37.0℃;
•Females with a positive urine pregnancy test or breastfeeding volunteers, volunteers or their partners who have a pregnancy plan within 6 months;
•Suffering from hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication (applicable to people aged 18 years and above);
•Those who have already suffered from one of the diphtheria or tetanus diseases, those who have suffered from whooping cough in the last 3 years; or those who have had persistent cough for 14 days or more in the last 6 months;
•Those who have received vaccine containing pneumococcal polysaccharide/conjugate component within 5 years (applicable to those aged 7 years and above);
•Individuals who have had household contact with an individual with a confirmed diagnosis of pertussis, diphtheria, or tetanus disease in the past 30 days;
•Individuals who are allergic to the components of the test vaccine (e.g., aluminum adjuvant, sodium dihydrogen phosphate, sodium chloride, etc.) or who have developed an allergy to the same type of vaccine previously; individuals with a previous history of severe allergy, e.g., recurrent generalized urticaria, anaphylactic shock, respiratory distress, angioneurotic edema, or a history of asthma;
•Those with encephalopathy, uncontrolled epilepsy and other progressive neurological disorders (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating diseases)
•Persons with primary and secondary impaired immune function, receiving immunosuppressive therapy
•Doctor-diagnosed coagulation abnormalities (e.g. coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders
+4 more criteria

Locations (1)

Kaihua County Center for Disease Control and Prevention

Kaihua, China

Key Dates

Start Date

December 20, 2024

Primary Completion Date

May 30, 2025

Completion Date

May 30, 2025

Last Updated

March 17, 2025

Enrollment

1,820

ACTUAL participants

Conditions

DiphtheriaTetanusPertussis

Interventions

Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))

BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (PPV23)

BIOLOGICAL

Tdcp

BIOLOGICAL

PPV23

BIOLOGICAL

Tdcp

BIOLOGICAL

PPV23

BIOLOGICAL

Tdcp

BIOLOGICAL

PPV23

BIOLOGICAL

Tdcp

BIOLOGICAL

Diphtheria-tetanus-acellular pertussis vaccine (DTaP)

BIOLOGICAL

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

NCT07203755

Diphtheria, Tetanus and Acellular PertussisEpidemic Meningitis+1 more

View study

RECRUITINGPHASE3

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

NCT07112144

Prevent Whooping CoughPrevent Diphtheria+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy