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

RECRUITINGPHASE3

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

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

NCT07112144•Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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;
+9 more criteria

Locations (1)

Yanshan County Center for Disease Control and Prevention

Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, China

Key Dates

Start Date

June 13, 2025

Primary Completion Date

June 1, 2032

Completion Date

June 1, 2032

Last Updated

August 8, 2025

Enrollment

1,650

ESTIMATED participants

Conditions

Prevent Whooping CoughPrevent DiphtheriaPrevent Tetanus

Interventions

DTacP

BIOLOGICAL

DTaP

BIOLOGICAL

DTacP-IPV/Hib

BIOLOGICAL

Contacts

huan xiao li

CONTACT

0431-87078176 lixiaohuan@bchtpharm.com