Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-3
SponsorChangchun BCHT Biotechnology Co.
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
DTacP
Biological/VaccineVaccinate 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
Biological/VaccineVaccinate 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
Biological/VaccineAdminister 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection
Treatment groups
1,650 Participants
are divided into 3 treatment groupsGroup A: DTacPExperimental treatment 1 intervention
Group B: DTaPActive comparator 1 intervention
Group C: DTacP-IPV/HibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
day 30 post-primary immunization2
Immunogenicity
Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-primary immunization
Time frame
day 30 post-primary immunizationSecondary outcomes
1
Immunogenicity
Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-primary immunization
Time frame
day 30 post-primary immunization2
Immunogenicity
Proportions of subjects with anti-PRN antibody levels ≥5, ≥10, and ≥20 IU/mL at day 30 post-primary immunization
Time frame
day 30 post-primary immunization3
Immunogenicity
Geometric mean concentrations (GMCs) of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization
Time frame
day 30 post-fourth booster immunization4
Immunogenicity
Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization
Time frame
day 30 post-fourth booster immunizationLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Yanshan County Center for Disease Control and PreventionRecruiting663100, Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan
China
ChinaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Changchun BCHT Biotechnology Co.
Lead sponsor
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
Source ClinicalTrials.gov