The objective of this proposal is to advance through Phase 2 testing in females of child-bearing potential and pregnant women, a live-attenuated, sporozoite-(SPZ-) based vaccine for preventing Plasmodium falciparum (Pf) malaria infection. Data from the three randomized, double-blind, placebo-controlled clinical trials of PfSPZ Vaccine supported by this grant will be assembled into a dossier for a scientific advisory meeting with the EMA to review plans for Phase 3 testing, EU-M4all submission, and licensure of the vaccine in Africa. Concurrently, regulatory, marketing, and distribution plans will be developed for four African countries.