Clinical Trial

A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Study acronym: DTaP
Active, Not Recruiting Phase 3
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Summary
The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence. PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-10-21; most recent amendment 2025-09-09.
Status change: Recruiting → Active, Not Recruiting 2023-06-15
Status change: Not Yet Recruiting → Recruiting 2021-10-26
Trial Details
NCT Number NCT05091619
Lead Sponsor China National Biotec Group Company Limited
Collaborators: Beijing Institute of Biological Products Co Ltd.
Conditions Whooping Cough, Diphtheria, Tetanus
Enrollment 2,898 participants
Start Date 2021-10-22
Primary Completion 2024-01-22 (estimated)
Study Completion 2027-09-22 (estimated)
Updated on ClinicalTrials.gov 2025-09-15