Dose Finding Trial of R21/Matrix-M in School Children
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * The child received four doses of R21/Matrix-M in the phase IIb study evaluating R21/MatrixM in Nanoro, Burkina Faso (VAC 076). * Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial. * The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study. * The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial. Exclusion Criteria: * The child is enrolled in another malaria vaccine trial. * The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine. * The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations. * The child has major congenital defects. * The child has anaemia associated with clinical signs of symptoms