Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 2 months
Healthy Volunteers: t
View:
• 2 months of age (60\
⁃ 89 days), willing to provide identification documents;
• The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical research protocol.
Locations
Other Locations
China
Changge Center for Disease Control and Prevention
RECRUITING
Xuchang
Contact Information
Primary
Peng Wan
peng.wan@cansinotech.com
022-58213600-6051
Time Frame
Start Date: 2025-03-23
Estimated Completion Date: 2026-01
Participants
Target number of participants: 780
Treatments
Experimental: Experimental vaccine group A, 2 months old
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
Experimental: Experimental vaccine group B, 2 months old
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
Experimental: Experimental vaccine group C, 2 months old
3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4
Related Therapeutic Areas
Sponsors
Leads: CanSino Biologics Inc.