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
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 3 months
Healthy Volunteers: t
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• 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.
Locations
Other Locations
China
Yanshan County Center for Disease Control and Prevention
RECRUITING
Wenshan Zhuang And Miao Autonomous Prefecture
Contact Information
Primary
huan xiao li
lixiaohuan@bchtpharm.com
0431-87078176
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2032-06
Participants
Target number of participants: 1650
Treatments
Experimental: DTacP
Active_comparator: DTaP
Active_comparator: DTacP-IPV/Hib
Related Therapeutic Areas
Sponsors
Leads: Changchun BCHT Biotechnology Co.
Collaborators: Guizhou Provincial Center for Disease Control and Prevention, Yunnan Provincial Center for Disease Control and Prevention, Shandong Provincial Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention