A vaccine against malaria which complements existing control tools is an urgent medical need. RTS,S/AS, a pre-erythrocytic candidate vaccine, which targets the circumsporozoite protein, is the most advanced in clinical development. The safety, immunogenicity and efficacy of this candidate vaccine have been investigated in a series of trials in children and infants in endemic African countries. The vaccine shows promise for providing important public health benefits and a multicenter Phase III trial has started in Africa, aiming to further characterize the efficacy of the candidate vaccine and generate the regulatory data required for the licensing approval of the vaccine.