NCT07112144 Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
| NCT ID | NCT07112144 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Changchun BCHT Biotechnology Co. |
| Condition | Prevent Whooping Cough |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,650 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2032-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,650 participants in total. It began in 2025-06-13 with a primary completion date of 2032-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Obtain the informed consent of the subject's legal guardian and sign the informed consent form; 3. The legal guardian of the subject can comply with the requirements of the clinical trial protocol. Exclusion Criteria: 1. History of pertussis, diphtheria, or tetanus; 2. Contact with individuals diagnosed with pertussis or diphtheria within the past 30 days; 3. Vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Hib vaccine; 4. 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); 5. Axillary temperature \>37.0°C on the day of enrollment\*; 6. 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.); 7. History of epilepsy, convulsions, or seizures, history of cerebral palsy, or family history of mental illness; 8. 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; 9. Asplenia or splenic dysfunction due to any cause; 10. Clinically diagnosed coagulation disorders (such as coagulation factor deficiencies, coagulation diseases, platelet abnormalities) or obvious bruising/coagulation disorders that may contraindicate intramuscular injection; 11. 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.); 12. Vaccination with subunit or inactivated vaccines within the past 7 days; vaccination with live attenuated vaccines within the past 14 days\*; 13. Receipt of immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) before enrollment; 14. 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); 15. Suffering from acute illnesses within 3 days before enrollment (acute illness is defined as moderate or severe illness with or without fever)\*; 16. Administration of prophylactic medications (such as antipyretic analgesics, antiallergic drugs, antidiarrheal drugs, etc.) within 3 days before enrollment\*; 17. 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); 18. Currently participating in other clinical trials or planning to participate in other trials during the study period; 19. Any other factors that, in the judgment of the researcher, make the subject unsuitable for participating in the clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07112144 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 3 Months, studying Prevent Whooping Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07112144 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,650 participants.
Is NCT07112144 currently recruiting?
Yes, NCT07112144 is actively recruiting participants. Contact the research team at lixiaohuan@bchtpharm.com for enrollment information.
Where is the NCT07112144 trial being conducted?
This trial is being conducted at Wenshan Zhuang and Miao Autonomous Prefecture, China.
Who is sponsoring the NCT07112144 clinical trial?
NCT07112144 is sponsored by Changchun BCHT Biotechnology Co.. The trial plans to enroll 1,650 participants.