Table 2.

Efficacy of RTS,S/AS01 (Mosquirix^®) in African children aged 5–17 months

Time point	No. of subjectsa (RTS,S/AS01 vs control)	Vaccine efficacy (%) [95% CI]
		Clinical malariab	Severe malariac	Malaria hospitalizationd
12 months after dose 3 [16]	2830 vs 1466	55.1 [50.5 to 59.3]**	47.3 [22.4 to 64.2]**	47.9 [34.6 to 58.5]**e
18 months after dose 3 [14]	4557 vs 2328	45.7 [41.7 to 49.5]**	35.5 [14.6 to 51.1]**	41.5 [29.1 to 51.7]**
30 months after dose 3 [13]
3 doses	2306 vs 2336	33.9 [28.9 to 38.6]**	2.1 [− 27.5 to 24.8]	18.1 [1.1 to 32.3]*e
3 doses + 1 booster dose	2276 vs 2336	46.1 [41.8 to 50.1]**	32.4 [9.5 to 49.8]	40.1 [26.2 to 51.5]*e*
46 months after dose 3 [13]
3 doses	2306 vs 2336	26.2 [20.8 to 31.2]**	− 5.8 [− 35.0 to 17.0]	12 [− 5 to 26]e
3 doses + 1 booster dose	2276 vs 2336	39.0 [34.3 to 43.3]**	28.5 [6.3 to 45.7]**	37.2 [23.6 to 48.5]e
Over 6.8 years [18]
3 doses	829 vs 839	19.1 [10.8 to 26.7]**	10.1 [− 18.1 to 31.6]	Not reportedf
3 doses + 1 booster dose	844 vs 839	23.7 [15.9 to 30.7]**	36.7 [14.6 to 53.1]**	Not reportedf

*p < 0.05, **p ≤ 0.01 vs comparator

^aModified intention-to-treat population for 6.8 years and per-protocol population for all other time points

^bAll episodes. Primary case definition: temperature ≥ 37.5 °C and P. falciparum asexual parasitaemia (> 5000 parasites/mm³) or a case of malaria meeting the primary case definition of severe malaria

^cPrimary case definition: P. falciparum asexual parasitaemia (> 5000 parasites/mm³) with ≥ 1 marker of disease severity and without comorbidity

^dDefined as a medical hospitalization with confirmed P. falciparum asexual parasitaemia (> 5000 parasites/mm³)

^eData from the EU assessment report [36] or summary of product characteristics[6]

^fVaccine efficacy was similar to that for severe malaria, as most severe malaria cases also met the case definition for malaria hospitalisation