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Dose Finding Trial of R21/Matrix-M in School Children

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Apr 2026 → Mar 2027
See other at-risk trials from University of Oxford

Record History

  1. Notable Primary completion pushed from Apr 2026 to Mar 2027
    • Enrollment closed, study ongoing
    • Site details revised
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 2025 to Feb 18, 2026
    • Primary completion date: Jan 2026 to Apr 2026
    • Study completion date: Dec 2026 to Mar 2027
    • Site details revised
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso. Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster. This trial is co-funded by the Serum Institute of India and Coefficient Giving.
Trial Details
NCT Number NCT07074665
Lead Sponsor University of Oxford
Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso
Conditions
(from sponsor)
Malaria (Plasmodium Falciparum)
Related terms Malaria, Falciparum
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov