A Phase III Randomized Controlled Multi-Centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical Malaria.

Objectives

Primary study objectives:

Efficacy:

1)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 (standard vaccination regime).

2)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 (seasonal vaccination regime).

Safety:

1)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.

Secondary objectives:

1)Efficacy against clinical malaria after a booster vaccination.

2)Efficacy against asymptomatic P. falciparum infection.

3)Efficacy against severe malaria disease.

4)Efficacy according to different transmission settings.

5)Efficacy against incident severe anaemia, blood transfusion requirement and malaria hospitalisation.

6)Safety and reactogenicity (including Serious adverse events (SAEs) and any deaths) following the booster vaccination and for the duration of the study.

7)Assessment of humoral immunogenicity by anti-CSP antibody concentrations measured 12 months after completion of the primary series of 3 vaccinations and 12 months after booster vaccination.