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Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Publications: details revised at 4 of 4 entries
  2. Primary completion date: Oct 30, 2024 to Jan 30, 2025
    • Study completion date: Oct 30, 2025 to Jan 30, 2027
    v11
  3. 2 versions Re-verified since Mar 13, 2024, no change to tracked fieldsv9-v10
  4. Primary completion date: Oct 30, 2022 to Oct 30, 2024
    • Study completion date: Oct 30, 2022 to Oct 30, 2025
    v8
  5. Primary and study completion dates: Sep 30, 2021 to Oct 30, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Sep 30, 2020 to Sep 30, 2021
    • Enrollment target: 24000 to 30000
    • Study description expanded, about 232 words
    v6
  2. Primary completion date: Jan 2021 to Sep 30, 2020
    • Study completion date: Jan 2021 to Sep 30, 2021
    v5
  3. Lead sponsor: University of Maryland to University of Maryland, Baltimore
    • Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v4
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2018 to Feb 21, 2018
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).
Trial Details
NCT Number NCT03299426
Lead Sponsor University of Maryland, Baltimore
Collaborators: Bill and Melinda Gates Foundation, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University College, London, University of Malawi
Conditions
(from sponsor)		 Typhoid
Related terms Typhoid Fever
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov