Diphtheria, Tetanus and Acellular PertussisPhase 3NCT05951725
A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)
A Phase 3 study testing Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP), Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP and Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib in people with Diphtheria, Tetanus and Acellular Pertussis, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus and Acellular Pertussis
- What is being tested?
- Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP), Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP and Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,520 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2023to 1 Apr 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 months of age (60~89 days), 3 months of age (90~119 days), willing to provide identification documents
- The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical study protocol
Who cannot join
- Infants 2 months of age who have received a vaccine containing the components of diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine
- Infants 3 months of age who have received vaccines containing diphtheria, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine or group A, group C meningococcal conjugate vaccine
- 3-month-old infant vaccinated with IPV
- Premature birth (delivery before the 37th week of gestation), low birth weight (birth weight <2500g) for 2-month-old (60-89 days) and 3-month-old (90-119 days) infants
- History of abnormal labor, asphyxia, and neurological damage
- Those who have suffered from pertussis, diphtheria or tetanus
Show all 26Show fewer
- Individuals who have had household contact with individuals with confirmed pertussis, diphtheria, or tetanus disease in the past 30 days
- History of allergy to vaccines or vaccine components, severe side effects to vaccines such as allergy, urticaria, respiratory distress, angioneurotic edema
- Those with a history of epilepsy, convulsions, convulsions, cerebral palsy, or a history of mental illness or family history; or other progressive neurological disorders
- Have been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune disease
- Any condition resulting in absence of spleen, defective spleen function
- Known or suspected acute disease or serious chronic disease (including: serious respiratory disease, serious cardiovascular disease, liver and kidney disease, serious skin disease, malignant tumor, etc.); or in the acute phase of chronic disease
- Physician-diagnosed coagulation abnormalities (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders
- Have had immunosuppressive or modifying agents, cytotoxic continuous treatment for more than 10 days in the past 6 months (except inhaled and topical steroids)
- Received blood products (except hepatitis B immunoglobulin) within 3 months prior to receiving the experimental vaccine
- Received another investigational drug or investigational vaccine within 1 month prior to receiving the experimental vaccine
- Plan to participate or are participating in any other drug clinical studies
- Received a live attenuated vaccine within 14 days prior to receiving the experimental vaccine, or received another vaccine within 7 days
- Those with fever before vaccination, axillary body temperature >37.0°C
- Any other factors that, in the judgment of the investigator, make participation in the clinical trial inappropriate
- 1-20 articles for the first dose exclusion criteria
- Those who had a severe allergic reaction after the previous dose of vaccine
- Persons with serious adverse reactions causally related to the previous dose of vaccination
- Newly discovered or newly occurred after the first vaccination that do not meet the first dose inclusion criteria or meet the first dose exclusion criteria will be determined by the investigator whether to continue to participate in the study
- Other reasons for exclusion as perceived by the researcher
- 22-25 for the 2nd, 3rd, 4th agent exclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site
Changge Center for Disease Control and Prevention
Xuchang, Henan, 461500
About this study
Official title: A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age
The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.
- Being tested
- Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP), Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP, Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib, DTcP, DTaP-IPV-Hib
- Keywords
- Vaccine, Three Components, Immunogenicity, Safety
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)Biological
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaPBiological
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-HibBiological
Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
DTcPBiological
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
DTaP-IPV-HibBiological
Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
DTcPBiological
Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Experimental vaccine group A，3 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 Receives: Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP) |
| Control vaccine group B，3 months old | Active comparator | 4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 Receives: Biological: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP |
| Control vaccine group C，3 months old | Active comparator | 4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 Receives: Biological: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib |
| Experimental vaccine group D，2 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 Receives: Biological: DTcP |
| Control vaccine group E，2 months old | Active comparator | 4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 Receives: Biological: DTaP-IPV-Hib |
| Experimental vaccine group F，2 months old | Experimental | 4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22 Receives: Biological: DTcP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
Measured: 30 days after completion of basal immunization
Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group
Measured: 30 days after completion of basal immunization
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
Measured: Within 0-30 days after each dose of vaccination
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group
Measured: Within 0-30 days after each dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start11 Aug 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diphtheria, Tetanus and Acellular PertussisStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951725
- Sponsor's protocol ID
- CS-CTP-DTcP-Ⅲ
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, Wei C, Huang H, Wang X, Xie Z, Wu Y, Wang F, Huang L, Wang X, Sui X, Wan P, Chao Z, Gou J, Shi B, Liu J, Zhu T, Yuan L, Wang Y. Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants. Front Immunol. 2026 Jul 7;17:1874647. doi: 10.3389/fimmu.2026.1874647. eCollection 2026.
PubMed 42483174
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age
- ClinicalTrials.gov ID
- NCT05951725
- Acronym / sponsor ID
- CS-CTP-DTcP-Ⅲ
- Keywords
- Vaccine, Three Components, Immunogenicity, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,520 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental vaccine group A，3 months old | Experimental | Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
| Control vaccine group B，3 months old | Active comparator | Biological: Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP4 doses of DTaP vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
| Control vaccine group C，3 months old | Active comparator | Biological: Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,15~21 |
| Experimental vaccine group D，2 months old | Experimental | Biological: DTcP4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 |
| Control vaccine group E，2 months old | Active comparator | Biological: DTaP-IPV-Hib4 doses of DTaP-IPV-Hib vaccine (0.5 ml) on Day 0 and Month 1,2,16~22 |
| Experimental vaccine group F，2 months old | Experimental | Biological: DTcP4 doses of DTcP vaccine (0.5 ml) on Day 0 and Month 2,4,16~22 |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2 months of age (60~89 days), 3 months of age (90~119 days), willing to provide identification documents
- The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical study protocol
Key exclusion criteria (26 listed)
- Infants 2 months of age who have received a vaccine containing the components of diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine
- Infants 3 months of age who have received vaccines containing diphtheria, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine or group A, group C meningococcal conjugate vaccine
- 3-month-old infant vaccinated with IPV
- Premature birth (delivery before the 37th week of gestation), low birth weight (birth weight <2500g) for 2-month-old (60-89 days) and 3-month-old (90-119 days) infants
- History of abnormal labor, asphyxia, and neurological damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Experimental vaccine group A，3 months old |
| Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaPThree doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Control vaccine group B，3 months old |
| Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-HibThree doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Control vaccine group C，3 months old |
| DTcPThree doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Experimental vaccine group D，2 months old |
| DTaP-IPV-HibThree doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Control vaccine group E，2 months old |
| DTcPThree doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age. | Biological | Experimental vaccine group F，2 months old |
Primary outcome
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group
Time frame: 30 days after completion of basal immunization
Serum anti-PT, FHA, PRN, DT, TT antibody positive conversion rate, Geometric Mean Concentration(GMC) 30 days after completion of basal immunization in subjects in the 2-month-old group
Time frame: 30 days after completion of basal immunization
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 3-month-old group
Time frame: Within 0-30 days after each dose of vaccination
Incidence of adverse reactions within 0-30 days after each dose of vaccination in subjects in the 2-month-old group
Time frame: Within 0-30 days after each dose of vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 42483174Zhang W, Wei C, Huang H, Wang X, Xie Z, Wu Y, Wang F, Huang L, Wang X, Sui X, Wan P, Chao Z, Gou J, Shi B, Liu J, Zhu T, Yuan L, Wang Y. Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants. Front Immunol. 2026 Jul 7;17:1874647. doi: 10.3389/fimmu.2026.1874647. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP), Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP and Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib in people with Diphtheria, Tetanus and Acellular Pertussis, run by CanSino Biologics Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum anti-Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), DT(Diphtheria Toxoid), TT(Tetanus Toxoid) antibody positive conversion rate,GMC 30 days after completion of basal immunization in subjects in the 3-month-old group (time frame: 30 days after completion of basal immunization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.