DiphtheriaPhase 2/3NCT06708286

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

A Phase 2/3 study testing Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Tdcp 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

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 (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Tdcp
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,820 participants
Where: 1 siteChina
Study dates: 20 Dec 2024to 30 Mar 2026
Phase: Phase 2/3

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

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

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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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Kaihua County Center for Disease Control and Prevention
Kaihua

Other trials in China

About this study

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

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
Being tested: Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp)), 23-valent Pneumococcal Polysaccharide Vaccine (PPV23), Tdcp, PPV23, Diphtheria-tetanus-acellular pertussis vaccine (DTaP)
Keywords: Vaccine, Five Components, Immunogenicity, Safety, 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 (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
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23Biological
1 dose of PPV23 vaccine (0.5ml) on day 0
TdcpBiological
1 dose of Tdcp vaccine (0.5ml) on day 0
Diphtheria-tetanus-acellular pertussis vaccine (DTaP)Biological
1 dose of DTaP vaccine (0.5ml) on day 0

Study groups in NCT06708286
Study group	Role	What they receive
Phase II, ≥18 years old, Experimental vaccine	Experimental	One dose of Tdcp on Day 0 Receives: 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 Receives: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)
Phase II, 7-17 years old, Experimental vaccine	Experimental	One dose of Tdcp on Day 0 Receives: Biological: Tdcp
Phase II, 7-17 years old, Control vaccine	Active comparator	One dose of PPV23 on Day 0 Receives: Biological: PPV23
Phase III, ≥18 years old, Experimental vaccine	Experimental	One dose of Tdcp on Day 0 Receives: Biological: Tdcp
Phase III, ≥18 years old, Control vaccine	Active comparator	One dose of PPV23 on Day 0 Receives: Biological: PPV23
Phase III, 7-17 years old, Experimental vaccine	Experimental	One dose of Tdcp on Day 0 Receives: Biological: Tdcp
Phase III, 7-17 years old, Control vaccine	Active comparator	One dose of PPV23 on Day 0 Receives: Biological: PPV23
Phase III, 6 years old, Experimental vaccine	Experimental	One dose of Tdcp on Day 0 Receives: Biological: Tdcp
Phase III, 6 years old, Control vaccine	Active comparator	One dose of DTaP on Day 0 Receives: Biological: Diphtheria-tetanus-acellular pertussis vaccine (DTaP)

What is being measured

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

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

Secondary outcomes (12)

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

Timeline

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

20 Dec 202430 Mar 2026

First posted27 Nov 2024
Study start20 Dec 2024
Primary completion1 Jul 2025
Study completion30 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiphtheriaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,820 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06708286
Sponsor's protocol ID: CTP-Tdcp-002
Status last verified: Aug 2026
First submitted: 25 Nov 2024
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 3
Study of BK1803 in Healthy Infants
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