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Of about 450 children, about 6% had antibodies to the protein; none of these children developed severe malaria (defined as difficulty breathing, convulsions, high fever, low blood sugar, or severe anemia).
A total of 1464 episodes of malaria, defined as documented fever or history of fever with any parasitemia on blood smear, occurred over the study period.
Efficacy (Malaria episodes) The primary endpoint was a clinical episode of malaria, defined as an axillary temperature greater than 37.5 degrees centigrade, with a Plasmodium falciparum parasitaemia greater than 2,500 parasites per ul.
The primary analysis was a log rank test comparing the time to the first or only episode of malaria (defined as fever with parasitaemia above 2500/µL) between the vaccination groups, stratified by age group, ITN (insecticide treated net) use and village, analysed by Intention To Treat.
Severe malaria defined as hospital admissions, was further divided into three categories namely: Cerebral Malaria (CM) with a Blantyre Coma Score (BCS) of ≤2 [55], [55], Severe malaria anaemia (SMA) had a haemoglobin concentration <5g per deciliter, [56] and Severe malaria-other (SM-other) patients with neither severe anaemia nor cerebral malaria (BCS>2).
The primary study endpoint was the incidence of the first or only episode of malaria, defined as a parasitaemia of 3000/µL or more together with fever (temperature measured by auricular thermometer ≥38.0°C) or a history of fever or vomiting in the previous 24 hours.
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A second definition of malaria was fever (defined as above) and a peripheral parasiteamia of >7000 parasites/µl blood, a local threshold with high specificity for clinical malaria [10].
Imported malaria is defined as malaria infection acquired in a malaria endemic area but diagnosed in a non-endemic country [ 4, 5].
Severe malaria is defined as acute malaria with major signs of organ dysfunction and/or high levels of parasitemia [ 3].
Clinical malaria was defined as symptoms of malaria and a positive blood smear for Plasmodium falciparum or P. malariae.
In this analysis, an imported case of malaria was defined as case of malaria acquired in a known malarious area outside China.
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