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BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa

Study acronym: BCG2-DTP3
StatusEnrolling by Invitation
PhasePhase 4
Started
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Record History

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  1. Secondary endpoints: details revised at 7 of 7 entries
    • Study description shortened, about 1 word
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections. In contrast, non-live diphtheria-tetanus-pertussis-containing (DTP) vaccine enhances susceptibility in females: DTP vs no DTP is associated with 2-fold higher mortality, and in DTP-vaccinated children, females have higher mortality than males. These effects are seen as long as a vaccine is the most recent vaccine. WHO recommends BCG at birth followed by three DTP vaccines. A metaanalysis based on observational studies has shown that co-administration of BCG+DTP is associated with lower mortality than BCG followed by DTP. The investigators will implement a randomised trial in urban Guinea-Bissau, including 6000 children, to test the hypothesis that an extra dose of BCG given with DTP3 (BCG2+DTP3 vs. DTP3) can: * reduce death and hospital admissions by 25% * reduce the F/M severe morbidity hazard ratio
Trial Details
NCT Number NCT07005726
Lead Sponsor Bandim Health Project
Collaborators: University of Southern Denmark, Radboud University Medical Center
Conditions
(from sponsor)		 Infant Morbidity, Infant Mortality, Non-Specific Effects of Vaccines, BCG
Related terms Infant Death
Enrollment 6,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov