RecruitingPhase 3

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

China1,650 participantsStarted 2025-06-13

Plain-language 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.

Who can participate

Age range2 Months – 3 Months

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Immunogenicity

Timeframe: day 30 post-primary immunization

Immunogenicity

Timeframe: day 30 post-primary immunization

Trial details

NCT IDNCT07112144

SponsorChangchun BCHT Biotechnology Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-06

Contact for this trial

huan xiao li

0431-87078176 lixiaohuan@bchtpharm.com

View on ClinicalTrials.gov More Prevent Whooping Cough trials