NCT06857370

Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria, Tetanus and Acellular Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)	Three doses of basic immunization were completed at 2, 4 and 6 months of age
BIOLOGICAL	Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)	Three doses of basic immunization were completed at 2, 4 and 6 months of age
BIOLOGICAL	Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)	Three doses of basic immunization were completed at 2, 4 and 6 months of age

Timeline

• Start date: 2025-03-23
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-03-04
• Last updated: 2025-08-15

Locations

1 site across 1 country: China