drugset / Trial / NCT07074665

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

NCT07074665

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2026-02-18
Primary completion
2026-04
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Matrix-M1 Adjuvant Other / unclassified 5 ug
Subject Matrix-M1 Adjuvant Other / unclassified 10 ug