Table 3.

Efficacy of seasonal malaria vaccination with RTS,S/AS01 (Mosquirix^®) over 3 years in African children aged 5–17 months in a randomized phase 3 trial [17]

Outcomes/treatmentsa	No. of events/100 person-year at risk [95% CI]	Protective efficacyb (%) [95% CI]
		Versus SMC alone	Versus RTS,S/AS01 alone
Uncomplicated clinical malariac
SMC alone	304.8 [290.5 to 319.8]
RTS,S/AS01 alone	278.2 [264.6 to 292.4]	7.9 [− 1.0 to 16.0]
RTS,S/AS01 + SMC	113.3 [104.7 to 122.5]	62.8 [58.4 to 66.8]	59.6 [54.7 to 64.0]
Hospitalization for severe malariad
SMC alone	6.8 [4.9 to 9.4]
RTS,S/AS01 alone	6.7 [4.8 to 9.2]	− 0.4 [− 60.2 to 37.1]
RTS,S/AS01 + SMC	2.0 [1.1 to 3.6]	70.5 [41.9 to 85.0]	70.6 [42.3 to 85.0]
Death from malaria
SMC alone	2.0 [1.1 to 3.6]
RTS,S/AS01 alone	2.2 [1.2 to 3.8]	− 9.5 [− 148.3 to 51.7]
RTS,S/AS01 + SMC	0.5 [0.2 to 1.7]	72.9 [2.9 to 92.4]	75.3 [12.5 to 93.0]

SMC seasonal malaria chemoprevention

^aOutcomes were assessed in modified intention-treat population (n = 1965, 1988, 1967 in the SMC, RTS,S/AS01 and combination groups, respectively; see main text for treatment details)

^bCalculated as (1−hazard ratio) × 100

^cPrimary outcome: defined as body temperature ≥ 37.5 °C or a history of fever within the previous 48 h and P. falciparum parasitemia (parasite density ≥ 5000 per mm³) in children who presented to a clinical trial health facility

^dClassified according to the WHO definition