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

NCT06708286 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CTP-Tdcp-002
• Study Type: interventional
• Target: 1,820
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

Vaccine; Five Components; Immunogenicity; Safety; Acellular

Outcome Measures

Primary Outcomes (4)

• Phase II: Incidence of adverse reactions

  Within 0-30 days after vaccination

• Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies

  Pre-vaccination and 30 days post-vaccination

• Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml

  30 days after vaccination

• Phase III: Incidence of adverse reactions

  Within 0-30 days after vaccination

Secondary Outcomes (12)

• Phase II: Incidence of adverse events/reactions

  Within 30 minutes of vaccination

• Phase II: Incidence of adverse events/reactions

  0-7 days after vaccination

• Phase II: Incidence of adverse events

  0-30 days after vaccination

• Phase II: Incidence of serious stadverse events

  Within 6 months of vaccination

• Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies

  30 days after vaccination

Study Arms (10)

Phase II, ≥18 years old, Experimental vaccine

EXPERIMENTAL

One dose of Tdcp on Day 0

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

Phase II, ≥18 years old, Control vaccine

ACTIVE COMPARATOR

One dose of PPV23 on Day 0

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)

Phase II, 7-17 years old, Experimental vaccine

EXPERIMENTAL

One dose of Tdcp on Day 0

Biological: Tdcp

Phase II, 7-17 years old, Control vaccine

ACTIVE COMPARATOR

One dose of PPV23 on Day 0

Biological: PPV23

Phase III, ≥18 years old, Experimental vaccine

EXPERIMENTAL

One dose of Tdcp on Day 0

Biological: Tdcp

Phase III, ≥18 years old, Control vaccine

ACTIVE COMPARATOR

One dose of PPV23 on Day 0

Biological: PPV23

Phase III, 7-17 years old, Experimental vaccine

EXPERIMENTAL

One dose of Tdcp on Day 0

Biological: Tdcp

Phase III, 7-17 years old, Control vaccine

ACTIVE COMPARATOR

One dose of PPV23 on Day 0

Biological: PPV23

Phase III, 6 years old, Experimental vaccine

EXPERIMENTAL

One dose of Tdcp on Day 0

Biological: Tdcp

Phase III, 6 years old, Control vaccine

ACTIVE COMPARATOR

One dose of DTaP on Day 0

Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP)

Interventions

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

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

Phase II, ≥18 years old, Experimental vaccine

23-valent Pneumococcal Polysaccharide Vaccine (PPV23) BIOLOGICAL

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

Phase II, ≥18 years old, Control vaccine

Tdcp BIOLOGICAL

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

Phase II, 7-17 years old, Experimental vaccine

PPV23 BIOLOGICAL

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

Phase II, 7-17 years old, Control vaccine

Diphtheria-tetanus-acellular pertussis vaccine (DTaP) BIOLOGICAL

1 dose of DTaP vaccine (0.5ml) on day 0

Phase III, 6 years old, Control vaccine

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently suffering from severe chronic diseases, acute exacerbation of chronic diseases, acute infectious diseases;
• Have received another investigational drug or vaccine within 1 month prior to receiving the experimental vaccine, or have plans to participate or are participating in a clinical study of any other drug;
• Have received an injectable live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or any other vaccine within 7 days prior to receiving the experimental vaccine;
• In the judgment of the investigator, the volunteer has any other factors that make him/her unsuitable for participation in the clinical trial.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Kaihua County Center for Disease Control and Prevention

Kaihua, China

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

Tetanus Toxoid; Vaccines, Combined; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Hanqing He

  Ethical Review Committee for Clinical Trials of Zhejiang Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-11

Locations

CN (1)