Table 4. Overall incidence of solicited local and general adverse events reported following 3 doses of the RTS,S/AS01 vaccine in the RTS,S coad and RTS,S alone groups (overall per dose) - exposed set.

Symptoms	RTS,S coad			RTS,S alone
	N	n	% (95% CI)	N	n	% (95% CI)
Solicited local adverse events at the RTS,S/AS01 injection site
Pain	675	36	5.3 (3.8–7.3)	698	38	5.4 (3.9–7.4)
Redness	675	11	1.6 (0.8–2.9)	698	16	2.3 (1.3–3.7)
Swelling	675	15	2.2 (1.2–3.6)	698	15	2.1 (1.2–3.5)
Solicited general adverse events
Drowsiness	676	17	2.5 (1.5–4.0)	698	15	2.1 (1.2–3.5)
Irritability/Fussiness	676	36	5.3 (3.8–7.3)	698	43	6.2 (4.5–8.2)
Loss of appetite	676	19	2.8 (1.7–4.4)	698	24	3.4 (2.2–5.1)
Measles/Rubella-like rash	676	0	0.0 (0.0–0.5)	698	0	0.0 (0.0–0.5)
Fever*
All	676	133	19.7 (16.7–22.9)	698	127	18.2 (15.4–21.3)
Grade 3	676	9	1.3 (0.6–2.5)	698	6	0.9 (0.3–1.9)

The RTS,S coad group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age and the YF and MR vaccines at 9 months of age; the RTS,S alone group received the RTS,S/AS01 vaccines at 6, 7.5 and 9 months of age.

N, number of documented doses on all visits combined; n, number of doses followed by the symptom after all visits; %, percentage of doses followed by the symptom after all visits; CI, confidence interval.

^*Fever was defined as temperature ≥ 37.5 °C for oral, axillary or tympanic route. Grade 3 Fever was defined as temperature > 39.0 °C.