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R21/Matrix-M in African Children Against Clinical Malaria

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

Record History

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  1. Study completion date: Sep 2027 to Apr 2028
    • Study description expanded, about 7 words
    v10
  2. Primary endpoints: 2 to 4v9 Show 5 more changesShow less
    • Study completion date: Mar 2026 to Sep 2027
    • Interventions: R21/Matrix-M (Biological), Rabies vaccine or Hepatitis A vaccine (Biological) to R21/Matrix-M (Biological), Rabies vaccine, Hepatitis A vaccine or Meningococcal vaccine (Biological)
    • Secondary endpoints: 9 to 13
    • Study description expanded, about 133 words
    • Study arms: 10 to 11
  3. Study completion date: Mar 2024 to Mar 2026v8 Show 5 more changesShow less
    • Interventions: R21/Matrix-M (Biological), Rabies vaccine (Biological) to R21/Matrix-M (Biological), Rabies vaccine or Hepatitis A vaccine (Biological)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 131 words
    • Study arms: 4 to 10
  4. Primary completion date changed from estimate of Mar 2023 to Mar 21, 2023v7
  5. Primary endpoints revised (2)v6 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Mar 2023
    • Study completion date: Dec 2023 to Mar 2024
    • Secondary endpoints: 3 to 9
    • Study description expanded, about 49 words
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study description expanded, about 10 words
    v5
  2. Primary endpoints revised (2)
    • Eligibility criteria shortened, about 21 words
    • Study description shortened, about 2 words
    v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 2021 to Apr 29, 2021
    v3
  4. Study title shortened, about 4 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase III randomized controlled multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria
Trial Details
NCT Number NCT04704830
Lead Sponsor University of Oxford
Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Malaria Research and Training Center, Bamako, Mali, KEMRI-Wellcome Trust Collaborative Research Program, Ifakara Health Institute Clinical Trial Facility, Bagamoyo Research and Training Centre, PO Box 74, Bagamoyo, Tanzania, London School of Hygiene and Tropical Medicine
Conditions
(from sponsor)		 Malaria
Related terms Malaria
Enrollment 4,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov