Table 1.
Serious adverse events.
| R3R |
R3C |
C3C |
||||
|---|---|---|---|---|---|---|
| N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | |
| At least one SAE (M0–SE) | ||||||
| 5–17M (children) | 2976 | 24.2% (22.7–25.8) | 2972 | 25.3% (23.7–26.9) | 2974 | 28.4% (26.8–30.1) |
| 6–12W (infants) | 2180 | 26.6% (24.8–28.5) | 2178 | 27.6% (25.8–29.6) | 2179 | 28.4% (26.5–30.4) |
| At least one SAE (M0–SE), excluding malaria | ||||||
| 5–17M (children) | 2976 | 22.6% (21.1–24.2) | 2972 | 23.7% (22.2–25.3) | 2974 | 26.4% (24.8–28.0) |
| 6–12W (infants) | 2180 | 25.8% (24.0–27.7) | 2178 | 26.7% (24.9–28.6) | 2179 | 27.1% (25.3–29.0) |
| At least one SAE within 30 days post–vaccination | ||||||
| 5–17M (children) | 2976 | 6.1% (5.3–7.0) | 2972 | 6.0% (5.1–6.9) | 2974 | 6.7% (5.8–7.6) |
| 6–12W (infants) | 2180 | 4.8% (4.0–5.8) | 2178 | 5.6% (4.7–6.7) | 2179 | 5.2% (4.3–6.2) |
| At least one SAE before dose 4 (M0–M20) | RTS,S/AS01 | Control | ||||
| 5–17M, all children | 5949 | 18.6% (17.6–19.6) | 2974 | 22.7% (21.2–24.3) | ||
| 5–17M, low weight-for-age | 695 | 25.0% (21.9–28.4) | 364 | 24.5% (20.1–29.2) | ||
| 5–17M, very low weight-for-age | 207 | 26.6% (20.7–33.1) | 97 | 28.9% (20.1–39.0) | ||
| 6–12W, all infants | 4358 | 22.0% (20.8–23.3) | 2179 | 23.1% (21.3–24.9) | ||
| 6–12W, low weight-for-age | 221 | 28.5% (22.7–34.9) | 126 | 30.2% (22.3–39.0) | ||
| 6–12W, very low weight-for-age | 147 | 32.7% (25.2–40.9) | 67 | 25.4% (15.5–37.5) | ||
| 6–12W, preterm | 244 | 19.7% (14.9–25.2) | 118 | 11.0% (6.0–18.1) | ||
| At least one SAE post-dose 4 (M21–SE) | R3R | R3C | C3C | |||
| 5–17M, all children | 2681 | 10.3% (9.2–11.5) | 2719 | 11.6% (10.4–12.9) | 2702 | 10.6% (9.5–11.8) |
| 5–17M, low weight-for-age | 277 | 11.6% (8.0–15.9) | 304 | 13.2% (9.6–17.5) | 297 | 12.8% (9.2–17.1) |
| 5–17M, very low weight-for-age | 48 | 10.4% (3.5–22.7) | 50 | 16.0% (7.2–29.1) | 60 | 18.3% (9.5–30.4) |
| 6–12W, all infants | 1966 | 9.2% (7.9–10.5) | 1996 | 9.7% (8.4–11.1) | 1976 | 10.2% (8.9–11.6) |
| 6–12W, low weight-for-age | 232 | 14.7% (10.4–19.9) | 211 | 10.0% (6.3–14.8) | 195 | 12.3% (8.0–17.8) |
| 6–12W, very low weight-for-age | 48 | 12.5% (4.7–25.2) | 47 | 19.1% (9.1–33.3) | 68 | 22.1% (12.9–33.8) |
| At least one fatal SAE (M0–SE) | R3R | R3C | C3C | |||
| 5–17M, all children | 2976 | 2.0% (1.6–2.6) | 2972 | 1.7% (1.3–2.3) | 2974 | 1.5% (1.1–2.1) |
| 5–17M, girls | 1467 | 2.4% (1.7–3.3) | 1500 | 2.1% (1.5–3.0) | 1503 | 1.1% (0.7–1.8) |
| 5–17M, boys | 1509 | 1.7% (1.1–2.5) | 1472 | 1.3% (0.8–2.0) | 1471 | 2.0% (1.3–2.8) |
| 6–12W, all infants | 2180 | 2.3% (1.7–3.1) | 2178 | 2.5% (1.9–3.3) | 2179 | 1.9% (1.4–2.6) |
| 6–12W, girls | 1064 | 2.5% (1.7–3.7) | 1060 | 2.7% (1.8–3.9) | 1100 | 1.5% (0.8–2.4) |
| 6–12W, boys | 1116 | 2.2% (1.4–3.2) | 1118 | 2.3% (1.5–3.4) | 1079 | 2.4% (1.6–3.5) |
| At least one fatal SAE within 30 days post-vaccination | R3R | R3C | C3C | |||
| 5–17M (children) | 2976 | 0.3% (0.1–0.6) | 2972 | 0.2% (0.1–0.4) | 2974 | 0.2% (0.1–0.4) |
| 6–12W (infants) | 2180 | 0.6% (0.3–1.0) | 2178 | 0.5% (0.3–0.9) | 2179 | 0.3% (0.1–0.6) |
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 children/infants in the group; %, percentage of children/infants with at least one SAE; M, months; W, weeks; SE, study end; CI, confidence interval; SAE, serious adverse event. Low weight-for-age defined as z-score ≤-2 but >-3, very low weight-for-age as z-score ≤-3.