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

Study acronym: DTaP
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Sep 22, 2023 to Jan 22, 2024v5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 22, 2023 to Sep 22, 2023
    • Site details revised at 4 of 4 sites
    v4
  3. Site details revised at 3 of 4 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05091619
Lead Sponsor China National Biotec Group Company Limited
Collaborators: Beijing Institute of Biological Products Co Ltd.
Conditions
(from sponsor)		 Whooping Cough, Diphtheria, Tetanus
Related terms Diphtheria, Tetanus, Whooping Cough
Enrollment 2,898 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov