Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

NCT ID: NCT07112144

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2032-06-30

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.

Conditions

Prevent Whooping Cough; Prevent Diphtheria; Prevent Tetanus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

DTacP

Group Type: EXPERIMENTAL

DTacP

Intervention Type: BIOLOGICAL

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；

DTaP

Group Type: ACTIVE_COMPARATOR

DTaP

Intervention Type: BIOLOGICAL

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/Hib

Group Type: ACTIVE_COMPARATOR

DTacP-IPV/Hib

Intervention Type: BIOLOGICAL

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

Interventions

DTacP

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；

Intervention Type: BIOLOGICAL

DTaP

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

Intervention Type: BIOLOGICAL

DTacP-IPV/Hib

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yunnan Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Shaanxi Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Guizhou Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Shandong Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Changchun BCHT Biotechnology Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yanshan County Center for Disease Control and Prevention

Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

huan xiao li

Role: CONTACT

lixiaohuan@bchtpharm.com

0431-87078176

Facility Contacts

cha yongxian cha

Role: primary

2209221135@qq.com

18164772650

Other Identifiers

B1004-F20240930-3

Identifier Type: -

Identifier Source: org_study_id