Diphtheria, Tetanus and Acellular PertussisPhase 3NCT06857370
Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
A Phase 3 study testing Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) and Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) in people with Diphtheria, Tetanus and Acellular Pertussis, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age. Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy 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 Lot 1), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) and Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2025to Jan 2026
- 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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 months of age (60~89 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 research protocol.
Who cannot join
- First dose exclusion criteria
- Persons who have received a vaccine containing the DPT classified vaccine;
- Premature labor (delivery before 37th week of gestation), low birth weight 60 (birth weight <2500g);
- Those with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage;
- Who have had one of the pertussis, diphtheria or tetanus diseases;
- Who have had household contact with an individual diagnosed with pertussis, diphtheria, or tetanus disease in the past 30 days;
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- Have a history of allergy to vaccines or vaccine components and severe side reactions to vaccines, such as hives, dyspnea, angioneurotic edema, and other allergic reactions;
- Persons with a history of seizures, convulsions, convulsions, or cerebral palsy; or a history or family history of psychiatric illness; or other progressive neurologic disorders;
- Have been diagnosed with an immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Juvenile Rheumatoid Arthritis ( Juvenile Rheumatoid Arthritis (JRA) or other autoimmune diseases;
- Any condition resulting in absence of spleen, defective spleen function;
- Known or suspected acute illness or severe chronic disease (including: severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignancy, etc.); or in an acute exacerbation of a chronic disease;
- Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
- Immunosuppressive or modifying agents, cytotoxic consecutive therapy for more than 10 days (except inhaled and topical steroids) within 2 months prior to receiving the test vaccine;
- Received blood products (other than hepatitis B immune globulin) within 2 months prior to receiving the test vaccine;
- Participated or planning to participate in any other drug or vaccine clinical study;
- Has received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to receiving the test vaccine;
- Axillary temperature >37.3°C prior to vaccination;
- Any other factor that, in the investigator's judgment, makes the subject unsuitable for participation in a clinical trial.
- Persons who have had a severe allergic reaction following a previous dose of vaccine;
- Persons with serious adverse reactions causally related to the previous dose of vaccination;
- Those with a newly identified or newly occurring condition after the first dose of vaccination that does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose, as determined by the investigator for continued participation in the study;
- Other reasons for exclusion as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Changge Center for Disease Control and Prevention
Xuchang, Henan, 461500
About this study
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.
- Being tested
- Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)
- Keywords
- Vaccine, Three Components, Immunogenicity, Safety, 2 months old
- 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 Lot 1)Biological
Three doses of basic immunization were completed at 2, 4 and 6 months of age
Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)Biological
Three doses of basic immunization were completed at 2, 4 and 6 months of age
Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)Biological
Three doses of basic immunization were completed at 2, 4 and 6 months of age
| Study group | Role | What they receive |
|---|---|---|
| Experimental vaccine group A, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 Receives: Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1) |
| Experimental vaccine group B, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 Receives: Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) |
| Experimental vaccine group C, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 Receives: Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Measured: 30 days after vaccination
Secondary outcomes (6)
Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Measured: 30 days after vaccination
Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine
Measured: 30 days after vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Measured: Within 30 minutes post-vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Measured: Within 0-7 days
Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.
Measured: Within 0-30 days
Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects.
Measured: From first vaccination to 30 days after the third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start23 Mar 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857370
- Sponsor's protocol ID
- CTP-DTcP-003
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
- ClinicalTrials.gov ID
- NCT06857370
- Acronym / sponsor ID
- CTP-DTcP-003
- Keywords
- Vaccine, Three Components, Immunogenicity, Safety, 2 months old
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 780 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Mar 2025 (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.
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental vaccine group A, 2 months old | Experimental | Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
| Experimental vaccine group B, 2 months old | Experimental | Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
| Experimental vaccine group C, 2 months old | Experimental | Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2 months of age (60~89 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 research protocol.
Key exclusion criteria (22 listed)
- First dose exclusion criteria
- Persons who have received a vaccine containing the DPT classified vaccine;
- Premature labor (delivery before 37th week of gestation), low birth weight 60 (birth weight <2500g);
- Those with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage;
- Who have had one of the pertussis, diphtheria or tetanus diseases;
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 Lot 1)Three doses of basic immunization were completed at 2, 4 and 6 months of age | Biological | Experimental vaccine group A, 2 months old |
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)Three doses of basic immunization were completed at 2, 4 and 6 months of age | Biological | Experimental vaccine group B, 2 months old |
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)Three doses of basic immunization were completed at 2, 4 and 6 months of age | Biological | Experimental vaccine group C, 2 months old |
Primary outcome
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Time frame: 30 days after vaccination
6 secondary outcomes
Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.
Time frame: 30 days after vaccination
Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine
Time frame: 30 days after vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 30 minutes post-vaccination
Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 0-7 days
Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.
Time frame: Within 0-30 days
Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects.
Time frame: From first vaccination to 30 days after the third dose
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 15 Aug 2025.
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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.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
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 Lot 1), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) and Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) 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 22 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 15 Aug 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?
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine. (time frame: 30 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.