Table 2.

Febrile convulsions incidence and self-controlled case-series analysis.

Incidence per 1,000 vaccine doses of febrile convulsions with diagnostic certainty level 1–3 (Brighton collaboration), within 7 days after each dose
	5–17months age category (children)			6–12 weeks age category (infants)
	N	n	Incidence (95% CI)	N	n	Incidence (95% CI)
First 3 doses
RTS,S/AS01	17,306	18	1.0 (0.6–1.6)	12,739	2	0.2 (0.0–0.6)
Control	8728	5	0.6 (0.2–1.3)	6403	3	0.5 (0.1–1.4)
Dose 4
R3R	2447	6	2.5 (0.9–5.3)	1825	4	2.2 (0.6–5.6)
R3C	2472	3	1.2 (0.3–3.5)	1837	0	0.0 (0.0–2.0)
C3C	2473	1	0.4 (0.0–2.3)	1827	1	0.5 (0.0–3.0)
SCCS Risk Ratio (95% CI) of febrile convulsions after each of the first 3 doses (5–17 months age category)
Risk period	R3R	R3C		R3R+R3C	C3C
3 days (days 0–2)	3.8 (1.7–8.7)	2.3 (0.8–6.0)		3.0 (1.6–5.6)	0.8 (0.2–3.5)
7 days (days 0–6)	1.9 (0.9–4.2)	2.2 (1.0–4.9)		2.1 (1.2–3.6)	1.1 (0.4–2.8)
SCCS Risk Ratio (95% CI) of febrile convulsions post-dose 4 (5–17 months age category)
Risk period	R3R	R3C			C3C
3 days (days 0–2)	6.0 (2.1–16.9)	4.5 (0.4–49.6)			0.0
7 days (days 0–6)	2.9 (1.0–7.9)	6.6 (0.6–72.5)			0.4 (0.1–2.9)

R3R, group receiving 4 doses of RTS,S/AS01; R3C, group receiving 3 doses of RTS,S/AS01 plus 1 dose of control vaccine; C3C, group receiving 4 doses of control vaccine; N, total number of vaccine doses administered in the group; n, number of vaccine doses followed by febrile convulsions; CI, confidence interval. Risk ratio is the risk ratio of the self-controlled case-series (SCCS) analysis, comparing the incidence in a given risk period (3 and 7 days post-vaccination) to the incidence in the corresponding control period (day 4–30 and day 8–30 post-vaccination, respectively).