Table 2 Major outcomes on the design of the Phase Ia/Ib clinical trials

• The clinical trial fast track strategy could be implemented where the Phase Ia and the Phase Ib will be staggered into a single clinical trial

• The clinical trial population from non-endemic areas will include male and female healthy adults

• The clinical trial population from endemic regions will be restricted to healthy nulligravid females with an upper age limit of 35 years and a lower age limit to be set according to the laws of majority governing the trial site

• The clinical trial will assess three dosages and the appropriate dosage of vaccine antigen will be around 50 µg

• Adjuvant would include aluminium hydroxide and a novel adjuvant.

• Placebo will be used in the malaria endemic-population

• The immunization schedule was agreed—three intramuscular doses will be administered at 0, 1 and 2 months