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ACTIVE NOT RECRUITING
NCT06857370
PHASE3

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

780

Start Date

2025-03-23

Completion Date

2026-01

Last Updated

2025-08-15

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Changge Center for Disease Control and Prevention

Xuchang, Henan, China