Table 6. Percentage of children reporting the most common (occurrence > 5% in at least one group) unsolicited adverse events - exposed set.
| RTS,S coad N = 231 | RTS,S alone N = 236 | Control N = 232 | ||||
|---|---|---|---|---|---|---|
| Unsolicited adverse events in all children | n | % (95%CI) | n | % (95% CI) | n | % (95% CI) |
| All | 191 | 82.7 (77.2–87.3) | 186 | 78.8 (73.0–83.8) | 174 | 75.0 (68.9–80.4) |
| Grade 3 | 9 | 3.9 (1.8–7.3) | 4 | 1.7 (0.5–4.3) | 7 | 3.0 (1.2–6.1) |
| Unsolicited adverse events reported by > 5% of children | ||||||
| Enteritis | 27 | 11.7 (7.8–16.5) | 27 | 11.4 (7.7–16.2) | 20 | 8.6 (5.3–13.0) |
| Conjunctivitis | 19 | 8.2 (5.0–12.5) | 17 | 7.2 (4.3–11.3) | 14 | 6.0 (3.3–9.9) |
| Dermatitis infected | 7 | 3.0 (1.2–6.1) | 18 | 7.6 (4.6–11.8) | 13 | 5.6 (3.0–9.4) |
| Gastroenteritis | 81 | 35.1 (28.9–41.6) | 89 | 37.7 (31.5–44.2) | 74 | 31.9 (25.9–38.3) |
| Malaria | 37 | 16.0 (11.5–21.4) | 37 | 15.7 (11.3–21.0) | 54 | 23.3 (18.0–29.3) |
| Otitis media | 15 | 6.5 (3.7–10.5) | 20 | 8.5 (5.3–12.8) | 10 | 4.3 (2.1–7.8) |
| Pneumonia | 32 | 13.9 (9.7–19.0) | 25 | 10.6 (7.0–15.2) | 19 | 8.2 (5.0–12.5) |
| Respiratory tract infection | 43 | 18.6 (13.8–24.2) | 52 | 22.0 (16.9–27.9) | 42 | 18.1 (13.4–23.7) |
| Rhinitis | 9 | 3.9 (1.8–7.3) | 12 | 5.1 (2.7–8.7) | 7 | 3.0 (1.2–6.1) |
| Upper respiratory tract infection | 111 | 48.1 (41.5–54.7) | 107 | 45.3 (38.9–51.9) | 101 | 43.5 (37.1–50.2) |
| Dermatitis | 12 | 5.2 (2.7–8.9) | 16 | 6.8 (3.9–10.8) | 8 | 3.4 (1.5–6.7) |
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; and the Control group received the YF and MR vaccines at 9 months of age.
N, number of children with at least one documented dose; n, number of children in whom the symptom was reported at least once; %, percentage of children in whom the symptom was reported at least once; CI, confidence interval; YF, yellow fever; MR, combined measles-rubella.
The follow-up period for unsolicited AEs was 30 days post-vaccination for the doses given at 6 and 7.5 months of age, and 42 days post-vaccination for the doses given at 9 months of age.