NCT07112144

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,650 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

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.

Conditions

• Prevent Whooping Cough
• Prevent Diphtheria
• Prevent Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	DTacP	Vaccinate 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；
BIOLOGICAL	DTaP	Vaccinate 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
BIOLOGICAL	DTacP-IPV/Hib	Administer 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection

Timeline

• Start date: 2025-06-13
• Primary completion: 2032-06-01
• Completion: 2032-06-01
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: China