Table 5. Incidence of solicited adverse events reported during the 14-day follow-up period post-vaccination at 9 months of age - exposed set.
| Symptom and vaccine site | RTS,S coad | RTS,S alone | Control | ||||||
|---|---|---|---|---|---|---|---|---|---|
| N | n | % (95% CI) | N | n | % (95% CI) | N | n | % (95% CI) | |
| Solicited local adverse events | |||||||||
| Pain | |||||||||
| RTS,S/AS01 dose 3 site | 220 | 8 | 3.6 (1.6–7.0) | 228 | 10 | 4.4 (2.1–7.9) | – | – | – |
| Combined measles-rubella vaccine site | 218 | 8 | 3.7 (1.6–7.1) | – | – | – | 225 | 1 | 0.4 (0.0–2.5) |
| Yellow fever vaccine site | 218 | 7 | 3.2 (1.3–6.5) | – | – | – | 225 | 1 | 0.4 (0.0–2.5) |
| Redness | |||||||||
| RTS,S/AS01 dose 3 site | 220 | 0 | 0.0 (0.0–1.7) | 228 | 1 | 0.4 (0.0–2.4) | – | – | – |
| Combined measles-rubella vaccine site | 218 | 0 | 0.0 (0.0–1.7) | – | – | – | 225 | 2 | 0.9 (0.1–3.2) |
| Yellow fever vaccine site | 218 | 0 | 0.0 (0.0–1.7) | – | – | – | 225 | 2 | 0.9 (0.1–3.2) |
| Swelling | |||||||||
| RTS,S/AS01 dose 3 site | 220 | 3 | 1.4 (0.3–3.9) | 228 | 3 | 1.3 (0.3–3.8) | – | – | – |
| Combined measles-rubella vaccine site | 218 | 0 | 0.0 (0.0–1.7) | – | – | – | 225 | 1 | 0.4 (0.0–2.5) |
| Yellow fever vaccine site | 218 | 0 | 0.0 (0.0–1.7) | – | – | – | 225 | 1 | 0.4 (0.0–2.5) |
| Solicited general adverse events | |||||||||
| Drowsiness | 221 | 7 | 3.2 (1.3–6.4) | 229 | 6 | 2.6 (1.0–5.6) | 225 | 0 | 0.0 (0.0–1.6) |
| Irritability/Fussiness | 221 | 11 | 5.0 (2.5–8.7) | 229 | 8 | 3.5 (1.5–6.8) | 225 | 1 | 0.4 (0.0–2.5) |
| Loss of appetite | 221 | 8 | 3.6 (1.6–7.0) | 229 | 6 | 2.6 (1.0–5.6) | 225 | 2 | 0.9 (0.1–3.2) |
| Measles/Rubella-like rash | 221 | 0 | 0.0 (0.0–1.7) | 0 | 0.0 (0.0–1.6) | 225 | 0 | 0.0 (0.0–1.6) | |
| Fever* | |||||||||
| All | 221 | 54 | 24.4(18.9–30.6) | 229 | 50 | 21.8 (16.7–27.8) | 225 | 17 | 7.6 (4.5–11.8) |
| Grade 3 | 221 | 3 | 1.4 (0.3–3.9) | 229 | 2 | 0.9 (0.1–3.1) | 225 | 2 | 0.9 (0.1–3.2) |
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 the corresponding documented dose; n, number of children in whom the symptom was reported following the corresponding dose; %, percentage of children in whom the symptom was reported following the corresponding dose; CI, confidence interval; RTS,S/AS01, pre-erythrocytic Plasmodium falciparum malaria vaccine; YF, yellow fever; MR, combined measles-rubella.
Fever was defined as temperature ≥ 37.5 °C for oral, axillary or tympanic route, or ≥ 38.0 °C for rectal route. The preferred route for recording temperature was axillary. Grade 3 Fever was defined as temperature > 39.0 °C.