Table 3. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Intention-to-Treat Cohort, According to the Vaccine Group.*.
| Events | RTS,S/AS01E | Rabies | |||
|---|---|---|---|---|---|
| No. of Subjects or Doses |
Percent (95% CI) | No. of Subjects or Doses |
Percent (95% CI) | ||
| SAEs, per-subject analysis | N = 447 | N = 447 | |||
| Any | 47 | 11 (8–14) | 82 | 18 (15–22) | |
| In absence of Plasmodium falciparum infection | 41 | 9 (8–14) | 61 | 14 (11–17) | |
| Pneumonia | 18 | 4 (2–6) | 26 | 6 (4–8) | |
| Gastroenteritis | 10 | 2 (1–4) | 21 | 5 (3–7) | |
| P. falciparum infection | 7 | 2 (1–3) | 21 | 5 (3–7) | |
| Death | 1 | <1 (0–1) | 1 | <1 (0–1) | |
| Related to vaccination | 1 | <1 (0–1) | 0 | 0 (0–1) | |
| Unsolicited AE, per-subject analysis | N = 447 | N = 447 | |||
| Any | 349 | 78 (74–82) | 332 | 74 (70–78) | |
| Gastroenteritis | 103 | 23 (19–27) | 83 | 19 (15–23) | |
| Pneumonia | 152 | 34 (30–39) | 143 | 32 (28–37) | |
| Upper respiratory tract infection | 81 | 18 (15–22) | 57 | 13 (10–16) | |
| Impetigo | 27 | 6 (4–9) | 20 | 5 (3–7) | |
| Lower respiratory tract infection | 27 | 6 (4–9) | 28 | 6 (4–9) | |
| Rhinitis | 27 | 6 (4–9) | 19 | 4 (3–7) | |
| Severity grade 3 | 36 | 8 (6–11) | 51 | 11 (9–15) | |
| Solicited local AEs, per-dose analysis | N = 1320 | N = 1320 | |||
| Pain | |||||
| Any | 172 | 13 (11–15) | 157 | 12 (10–14) | |
| Severity grade 3 | 0 | 0 (0–0) | 0 | 0 (0–0) | |
| Swelling | |||||
| Any | 34 | 3 (2–4) | 16 | 1 (1–2) | |
| Severity grade 3 | 3 | <1 (0–1) | 0 | 0 (0–0) | |
| Solicited systemic AEs, per-dose analysis | N = 1320 | N = 1318 | |||
| Drowsiness | |||||
| Any | 81 | 6 (5–8) | 64 | 5 (4–6) | |
| Severity grade 3 | 0 | 0 (0–0) | 1 | <1 (0–0) | |
| Related to vaccination | 69 | 5 (4–7) | 60 | 5 (4–6) | |
| Irritability | |||||
| Any | 59 | 5 (3–6) | 21 | 2 (1–2) | |
| Severity grade 3 | 0 | 0 (0–0) | 0 | 0 (0–0) | |
| Related to vaccination | 44 | 3 (2–4) | 16 | 1 (1–2) | |
| Loss of appetite | |||||
| Any | 64 | 5 (4–6) | 43 | 3 (2–4) | |
| Severity grade 3 | 0 | 0 (0–0) | 2 | <1 (0–1) | |
| Related to vaccination | 29 | 2 (2–3) | 16 | 1 (1–2) | |
| Fever† | |||||
| Any | 149 | 11 (10–13) | 409 | 31 (29–34) | |
| Severity grade 3 | 5 | <1 (0–1) | 12 | 1 (1–2) | |
| Related to vaccination | 132 | 10 (8–12) | 396 | 30 (28–33) | |
The three most common severe adverse events (SAEs) are listed individually, as are unsolicited adverse events (AEs) (those reported by parents spontaneously rather than in response to questions from field-workers) occurring in more than 5% of children in each group. SAEs are reported for the period from the first dose of vaccine until the unblinding of the database on August 4, 2008. Unsolicited AEs were recorded during the first 30 days (including the day of vaccination). Local AEs and solicited systemic AEs are reported for the first 7 days (including the day of vaccination) after each of the three vaccinations. Data on events reported per vaccine dose were available for the 447 subjects receiving the first dose in each group, for the 439 subjects in the RTS,S/AS01E group and the 438 in the rabies-vaccine group who received the second dose, and for the 434 subjects in the RTS,S/AS01E group and the 433 in the rabies-vaccine group who received the third dose — for a total of 1320 and 1318 doses in the respective groups.
Fever was defined as an axillary temperature of 37.5°C or greater.