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

NCT06857370 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2025-08-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-23
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857370 on ClinicalTrials.gov