Table 1.

Efficacy endpoints

Primary Efficacy Endpoint	Efficacy against clinical malaria when primary immunization starts at 6-12 weeks, or 5-17 months of age Occurrence of cases of malaria meeting the primary case definition for clinical malaria over a period starting 14 days post Dose 3 for 12 months in children aged 6-12 weeks
	Occurrence of cases of malaria meeting the primary case definition for clinical malaria over a period starting 14 days post Dose 3 for 12 months in children aged 5-17
Secondary Efficacy Endpoints	Efficacy against severe disease Occurrence of severe malaria meeting the primary and secondary case definitions
	Efficacy against incident severe anaemia and malaria hospitalization Occurrence of incident severe anaemia and malaria hospitalization meeting the primary and secondary case definitions
	Duration of efficacy of a primary course For a primary schedule without a boost, the occurrence of clinical malaria meeting the primary case definition analysed over the time periods starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end
	Potential added benefit of a booster dose For a primary schedule with and without a boost, the occurrence of clinical malaria meeting the primary case definition analysed over the time period starting at boost until study end
	Efficacy under different transmission settings For each site, occurrence of clinical malaria disease meeting the primary case definitions
	Efficacy against secondary case definitions of clinical malaria Occurrence of clinical malaria disease meeting the secondary case definitions
	Efficacy against prevalence of parasitaemia Presence of parasitaemia at 18 months and 30 months post Dose 3 and 12 months after the booster dose
	Efficacy against prevalence of moderate and severe anaemia Presence of moderate and severe anaemia at 18 months and 30 months post Dose 3 and 12 months after the booster dose
	Efficacy against other serious illness Occurrence of other serious illness meeting the primary and secondary case definitions. Other serious illness is all medical hospitalization, sepsis and pneumonia
	Efficacy against fatal malaria and all-cause mortality Occurrence of fatal malaria (meeting the case definitions) and all-cause mortality
	Effect on growth Compare the height/length, weight and mid-upper arm circumference for age z-score
	Gender-specific efficacy In male and female children, the occurrence of clinical malaria disease meeting the primary case definition