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Blood Donor CVD 5000

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary and study completion dates: May 31, 2025 to Jun 30, 2030v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary and study completion dates: Jun 30, 2024 to May 31, 2025
    • Site contact updated
    v7
  5. 4 versions Re-verified since May 14, 2020, no change to tracked fieldsv3-v6
  6. Lead sponsor: University of Maryland to University of Maryland, Baltimorev2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
Trial Details
NCT Number NCT03971669
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Risk Reduction
Related terms Risk Reduction Behavior, Typhoid Fever
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov