CompletedNCT06708286Updated Aug 26, 2026

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

A Phase 2/3 interventional study of Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in Diphtheria, Tetanus and Pertussis, sponsored by CanSino Biologics Inc.. Completed at 1 site in China. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by CanSino Biologics Inc. · Phase 2/3, Interventional, and Prevention

Phase: Phase 2/3
Study type: Interventional
Enrollment: 1,820
Allocation: Randomized
Ages: 6 Years and older
Sex: All

Study 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 studied

Diphtheria
Tetanus
Pertussis

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Keywords

Vaccine
Five Components
Immunogenicity
Safety
Acellular

Who can participate

Ages eligible: 6 Years and older
Sexes eligible: All
Accepts 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

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
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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,820 participants (actual)

Study arms

Experimental
Phase II, ≥18 years old, Experimental vaccine
One dose of Tdcp on Day 0
Biological: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))
Active comparator
Phase II, ≥18 years old, Control vaccine
One dose of PPV23 on Day 0
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)
Experimental
Phase II, 7-17 years old, Experimental vaccine
One dose of Tdcp on Day 0
Biological: Tdcp
Active comparator
Phase II, 7-17 years old, Control vaccine
One dose of PPV23 on Day 0
Biological: PPV23
Experimental
Phase III, ≥18 years old, Experimental vaccine
One dose of Tdcp on Day 0
Biological: Tdcp
Active comparator
Phase III, ≥18 years old, Control vaccine
One dose of PPV23 on Day 0
Biological: PPV23
Experimental
Phase III, 7-17 years old, Experimental vaccine
One dose of Tdcp on Day 0
Biological: Tdcp
Active comparator
Phase III, 7-17 years old, Control vaccine
One dose of PPV23 on Day 0
Biological: PPV23
Experimental
Phase III, 6 years old, Experimental vaccine
One dose of Tdcp on Day 0
Biological: Tdcp
Active comparator
Phase III, 6 years old, Control vaccine
One dose of DTaP on Day 0
Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP)

Interventions

BiologicalTetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))
1 dose of Tdcp vaccine (0.5ml) on day 0
Biological23-valent Pneumococcal Polysaccharide Vaccine (PPV23)
1 dose of PPV23 vaccine (0.5ml) on day 0
BiologicalTdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
BiologicalPPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
BiologicalTdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
BiologicalPPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
BiologicalTdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
BiologicalPPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
BiologicalTdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
BiologicalDiphtheria-tetanus-acellular pertussis vaccine (DTaP)
1 dose of DTaP vaccine (0.5ml) on day 0

What researchers measure

Primary outcomes

Phase II: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: Pre-vaccination and 30 days post-vaccination
Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
Time frame: 30 days after vaccination
Phase III: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination

Secondary outcomes

Phase II: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase II: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase II: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase II: Incidence of serious stadverse events
Time frame: 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
Time frame: 30 days after vaccination
Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase III: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase III: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase III: Incidence of SAEs in subjects aged 7 years and older
Time frame: Within 6 months of vaccination
Phase III: Incidence of SAEs in subjects aged 6 years
Time frame: Within 12 months of vaccination

Other outcomes

Seropositivity rates of antibodies against PT, FHA, PRN, FIM2&3, DT, and TT in the immunopersistence subgroup
Time frame: 12 months, 3 years, and 5 years post-vaccination
Geometric mean concentrations (GMC) of antibodies against PT, FHA, PRN, FIM2&3, DT, and TT in the immunopersistence subgroup
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 5 IU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2&3 antibodies ≥ 5 EU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 10 IU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2&3 antibodies ≥ 10 EU/mL
Time frame: 30 days, 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-PRN antibodies ≥ 20 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-FIM2 & 3 antibodies ≥ 20 EU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-DT antibodies ≥ 0.1 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination
The proportion of serum anti-TT antibodies ≥ 0.1 IU/mL
Time frame: 12 months, 3 years, and 5 years post-vaccination

Study locations

1 site

Kaihua County Center for Disease Control and Prevention
Kaihua, China

Registry details

Key details

Study ID: NCT06708286
Lead sponsor: CanSino Biologics Inc.
Responsible party: Sponsor
First posted: Nov 27, 2024
Start date: Dec 20, 2024
Primary completion: Jul 1, 2025
Completion: Mar 30, 2026
Last update: Aug 26, 2026

Study contacts

Hanqing He

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

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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