Prevent Whooping CoughPhase 3NCT07112144
Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
A Phase 3 study testing DTacP, DTaP and DTacP-IPV/Hib in people with Prevent Whooping Cough and Prevent Diphtheria, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months. Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Prevent Whooping Cough, Prevent Diphtheria, Prevent Tetanus
- What is being tested?
- DTacP, DTaP and DTacP-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to Jun 2032
- 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
- Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the subject and their legal guardian;
- Obtain the informed consent of the subject's legal guardian and sign the informed consent form;
- The legal guardian of the subject can comply with the requirements of the clinical trial protocol.
Who cannot join
- History of pertussis, diphtheria, or tetanus;
- Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days;
- Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine;
- Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth weight infants (<2500g);
- Axillary temperature >37.0°C on the day of enrollment*;
- Severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, or congenital diseases (such as Down syndrome, sickle cell anemia, congenital nervous system diseases, etc.);
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- History of epilepsy, convulsions, or seizures, history of cerebral palsy, or family history of mental illness;
- Autoimmune diseases or immunodeficiencies (such as perianal abscesses suggesting possible immunodeficiency in infants, human immunodeficiency virus infection, lymphoma, leukemia, etc.), or parents/siblings with autoimmune diseases or immunodeficiencies;
- Asplenia or splenic dysfunction due to any cause;
- Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation diseases, platelet abnormalities) or obvious bruising/coagulation disorders that may contraindicate intramuscular injection;
- History of severe allergic diseases (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reactions), history of severe allergic reactions to any vaccine (widespread urticaria, angioedema, etc.), or allergy to any known component of the test vaccine (pertussis toxoid, filamentous hemagglutinin, 69KD outer membrane protein, diphtheria toxoid, tetanus toxoid, aluminum hydroxide, sodium chloride, sodium hydroxide, etc.);
- Vaccination with subunit or inactivated vaccines within the past 7 days; vaccination with live attenuated vaccines within the past 14 days*;
- Receipt of immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) before enrollment;
- Receipt of any immunostimulant or immunosuppressant therapy before enrollment (continuous oral administration or infusion for ≥14 days, or topical steroid use [inhaled, nasal spray, intra-articular, eye drops, ointments, etc.] exceeding the recommended dosage in the package insert);
- Suffering from acute illnesses within 3 days before enrollment (acute illness is defined as moderate or severe illness with or without fever)*;
- Administration of prophylactic medications (such as antipyretic analgesics, antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment*;
- Known or suspected severe clinically diagnosed diseases (including but not limited to severe diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors);
- Currently participating in other clinical trials or planning to participate in other trials during the study period;
- Any other factors that, in the judgment of the researcher, make the subject unsuitable for participating in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yanshan County Center for Disease Control and Prevention
Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, 663100
cha yongxian cha, 18164772650, 2209221135@qq.com
About this study
Official title: Phase III Clinical Trials to Evaluate the Immunogenicity and Safety of Adsorption-free Diphtheria and Tetanus (Three-component) Combined Vaccine in 2-month-old Infants and Young Children
The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.
- Conditions
- Prevent Whooping Cough, Prevent Diphtheria, Prevent Tetanus
- Being tested
- DTacP, DTaP, DTacP-IPV/Hib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTacPBiological
Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml；Injection；
DTaPBiological
Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml.Injection
DTacP-IPV/HibBiological
Administer 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection
| Study group | Role | What they receive |
|---|---|---|
| DTacP | Experimental | Not described Receives: Biological: DTacP |
| DTaP | Active comparator | Not described Receives: Biological: DTaP |
| DTacP-IPV/Hib | Active comparator | Not described Receives: Biological: DTacP-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
The geometric mean concentration (GMC) of anti-PT antibody, anti-FHA antibody, anti-PRN antibody, anti-DT antibody, and anti-TT antibody at 30 days post-primary immunization
Measured: day 30 post-primary immunization
Immunogenicity
Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-primary immunization
Measured: day 30 post-primary immunization
Secondary outcomes (6)
Immunogenicity
Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-primary immunization
Measured: day 30 post-primary immunization
Immunogenicity
Proportions of subjects with anti-PRN antibody levels ≥5, ≥10, and ≥20 IU/mL at day 30 post-primary immunization
Measured: day 30 post-primary immunization
Immunogenicity
Geometric mean concentrations (GMCs) of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization
Measured: day 30 post-fourth booster immunization
Immunogenicity
Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization
Measured: day 30 post-fourth booster immunization
Immunogenicity
Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization
Measured: day 30 post-fourth booster immunization
Safety
Incidence of adverse events (AEs) and serious adverse events (SAEs) following each vaccination
Measured: At 12 months post-complete vaccination series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start13 Jun 2025
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevent Whooping CoughStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.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
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yunnan Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Guizhou Provincial Center for Disease Control and Prevention, Shandong Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112144
- Sponsor's protocol ID
- B1004-F20240930-3
- Status last verified
- Aug 2025
- First submitted
- 15 Jun 2025
- Last updated
- 8 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trials to Evaluate the Immunogenicity and Safety of Adsorption-free Diphtheria and Tetanus (Three-component) Combined Vaccine in 2-month-old Infants and Young Children
- ClinicalTrials.gov ID
- NCT07112144
- Acronym / sponsor ID
- B1004-F20240930-3
- Conditions
- Prevent Whooping Cough, Prevent Diphtheria, Prevent Tetanus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- Yunnan Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Guizhou Provincial Center for Disease Control and Prevention, Shandong Provincial Center for Disease Control and Prevention
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 8 Aug 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.
The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.
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 |
|---|---|---|
| DTacP | Experimental | Biological: DTacP |
| DTaP | Active comparator | Biological: DTaP |
| DTacP-IPV/Hib | Active comparator | Biological: DTacP-IPV/Hib |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants and young children who are permanent residents aged 2 months (60-89 days), and can provide valid identification documents for the subject and their legal guardian;
- Obtain the informed consent of the subject's legal guardian and sign the informed consent form;
- The legal guardian of the subject can comply with the requirements of the clinical trial protocol.
Key exclusion criteria (19 listed)
- History of pertussis, diphtheria, or tetanus;
- Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days;
- Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine;
- Premature infants (born before 37 weeks of gestation), infants with severe abnormal labor processes or a history of asphyxia rescue, or low birth weight infants (<2500g);
- Axillary temperature >37.0°C on the day of enrollment*;
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 |
|---|---|---|
| DTacPVaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml；Injection； | Biological | DTacP |
| DTaPVaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml.Injection | Biological | DTaP |
| DTacP-IPV/HibAdminister 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection | Biological | DTacP-IPV/Hib |
Primary outcome
Immunogenicity
Time frame: day 30 post-primary immunization
The geometric mean concentration (GMC) of anti-PT antibody, anti-FHA antibody, anti-PRN antibody, anti-DT antibody, and anti-TT antibody at 30 days post-primary immunization
Immunogenicity
Time frame: day 30 post-primary immunization
Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-primary immunization
6 secondary outcomes
Immunogenicity
Time frame: day 30 post-primary immunization
Immunogenicity
Time frame: day 30 post-primary immunization
Immunogenicity
Time frame: day 30 post-fourth booster immunization
Immunogenicity
Time frame: day 30 post-fourth booster immunization
Immunogenicity
Time frame: day 30 post-fourth booster immunization
Safety
Time frame: At 12 months post-complete vaccination series
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 8 Aug 2025.
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.
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 DTacP, DTaP and DTacP-IPV/Hib in people with Prevent Whooping Cough and Prevent Diphtheria, run by Changchun BCHT Biotechnology Co. 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 3 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 8 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?
Contact huan xiao li (0431-87078176, lixiaohuan@bchtpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: day 30 post-primary immunization). The study lists 2 primary outcomes in all. 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 8 Aug 2025.