Project Description

Study Title: A Phase III randomized controlled multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria

Chief Investigator: Professor Adrian Hill

Sponsor: University of Oxford

Funders: 

Primary Outcome Measures  :

  1. Efficacy: To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-36 month old children living in a malaria endemic area, 12 months after completion of the primary course. [ Time Frame: 2 years ]
    The primary efficacy outcome is clinical malaria, according to the primary case definition: the presence of axillary temperature ≥37.5°C and/ or history of fever within the last 24 hours, and P. falciparum asexual parasitaemia >5000 parasites/μL.This will assessed separately for seasonal and standard vaccination regimes.
  2. Safety: To assess the safety and reactogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, in the month following each vaccination, and 12 months after completion of the primary course. [ Time Frame: 2 years ]
    • Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination.
    • Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.
    • Occurrence of unsolicited adverse events for 28 days following the vaccination.
    • Change from baseline for safety laboratory measures thought to be clinically significant.
    • Occurrence of serious adverse events for the whole study duration.