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

NCT07112144 | Recruiting Phase 3

• 1 other identifier: B1004-F20240930-3
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  day 30 post-primary immunization

Secondary Outcomes (6)

• Immunogenicity

  day 30 post-primary immunization

• Immunogenicity

  day 30 post-primary immunization

• Immunogenicity

  day 30 post-fourth booster immunization

• Immunogenicity

  day 30 post-fourth booster immunization

• Immunogenicity

  day 30 post-fourth booster immunization

Study Arms (3)

DTacP

EXPERIMENTAL

Biological: DTacP

DTaP

ACTIVE COMPARATOR

Biological: DTaP

DTacP-IPV/Hib

ACTIVE COMPARATOR

Biological: DTacP-IPV/Hib

Interventions

DTacP 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

DTaP 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

DTacP-IPV/Hib 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

DTacP-IPV/Hib

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.);
• 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)\*;

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• Yunnan Provincial Center for Disease Control and Prevention: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator
• Guizhou Provincial Center for Disease Control and Prevention: collaborator
• Shandong Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Yanshan County Center for Disease Control and Prevention

Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, 663100, China

RECRUITING

Central Study Contacts

huan xiao li

CONTACT

0431-87078176; lixiaohuan@bchtpharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: August 8, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)