Table 1.
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 |
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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 |
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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 |
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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 |
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Efficacy under different transmission settings For each site, occurrence of clinical malaria disease meeting the primary case definitions |
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Efficacy against secondary case definitions of clinical malaria Occurrence of clinical malaria disease meeting the secondary case definitions |
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Efficacy against prevalence of parasitaemia Presence of parasitaemia at 18 months and 30 months post Dose 3 and 12 months after the booster dose |
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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 |
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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 |
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Efficacy against fatal malaria and all-cause mortality Occurrence of fatal malaria (meeting the case definitions) and all-cause mortality |
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Effect on growth Compare the height/length, weight and mid-upper arm circumference for age z-score |
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Gender-specific efficacy In male and female children, the occurrence of clinical malaria disease meeting the primary case definition |