Table 2. Number and percentage of HIV-infected participants for whom serious adverse events were reported during the specified periods, overall and by age category (ITT population of HIV-infected participants).
| R3R | R3C | C3C | ||||
|---|---|---|---|---|---|---|
| N | n (%, 95% CI) | N | n (%, 95% CI) | N | n (%, 95% CI) | |
| At least one SAE between dose 1 and study end | ||||||
| Total | 51 | 47 (92.2, 81.1-97.8) | 54 | 46 (85.2, 72.9-93.4) | 48 | 42 (87.5, 74.8-95.3) |
| 5–17 months | 24 | 22 (91.7, 73.0–99.0) | 29 | 24 (82.8, 64.2–94.2) | 32 | 27 (84.4, 67.2–94.7) |
| 6–12 weeks | 27 | 25 (92.6, 75.7–99.1) | 25 | 22 (88.0, 68.8–97.5) | 16 | 15 (93.8, 69.8–99.8) |
| At least one SAE (excluding HIV infectiona) between dose 1 and study end | ||||||
| Total | 51 | 43 (84.3, 71.4–93.0) | 54 | 44 (81.5, 68.6–90.7) | 48 | 40 (83.3, 69.8–92.5) |
| 5–17 months | 24 | 21 (87.5, 67.6–97.3 | 29 | 23 (79.3, 60.3–92.0) | 32 | 27 (84.4, 67.2–94.7) |
| 6–12 weeks | 27 | 22 (81.5, 61.9–93.7) | 25 | 21 (84.0, 63.9–95.5) | 16 | 13 (81.3, 54.4–96.0) |
| Fatalities between dose 1 and study end | ||||||
| Total | 51 | 15 (29.4, 17.5–43.8) | 54 | 15 (27.8, 16.5–41.6) | 48 | 15 (31.3, 18.7–46.3) |
| 5–17 months | 24 | 6 (25.0, 9.8–46.7) | 29 | 6 (20.7, 8.0–39.7) | 32 | 11 (34.4, 18.6–53.2) |
| 6–12 weeks | 27 | 9 (33.3, 16.5–54.0) | 25 | 9 (36.0, 18.0–57.5) | 16 | 4 (25.0, 7.3–52.4) |
| At least one SAE within 30 days after any of the first 3 doses | ||||||
| Total | 51 | 14 (27.5, 15.9–41.7) | 54 | 16 (29.6, 18.0–43.6) | 48 | 12 (25.0, 13.6–39.6) |
| 5–17 months | 24 | 7 (29.2, 12.6–51.1) | 29 | 6 (20.7, 8.0–39.7) | 32 | 10(31.3, 16.1–50.0) |
| 6–12 weeks | 27 | 7 (25.9, 11.1–46.3) | 25 | 10 (40.0, 21.1–61.3) | 16 | 2 (12.5, 1.6–38.3) |
| At least one SAE within 30 days after dose 4 | ||||||
| Total | 33 | 4 (12.1, 3.4–28.2) | 35 | 3 (8.6, 1.8–23.1) | 28 | 1 (3.6, 0.1–18.3) |
| 5–17 months | 17 | 2 (11.8, 1.5–36.4) | 22 | 2 (9.1, 1.1–29.2) | 20 | 1 (5.0,0.1–24.9) |
| 6–12 weeks | 16 | 2 (12.5, 1.6–38.3) | 13 | 1 (7.7,0.2–36.0) | 8 | 0 (0.0, 0.0–36.9) |
ITT, intent-to-treat; R3R, group receiving 4 doses of RTS,S/AS01; R3C, group receiving 3 doses of RTS,S/AS01 plus 1 dose of comparator vaccine; C3C, group receiving 4 doses of comparator vaccine; N, number of participants with at least one administered vaccine dose; for SAEs reported within 30 days after dose 4, N represents the number of participants who received dose 4; n (%), number (percentage) of participants reporting the event at least once; CI, confidence interval; SAE, serious adverse event.
a
Excluding SAEs with Medical Dictionary for Regulatory Activities codes referring to HIV infection: “HIV infection”, “HIV infection WHO clinical stage II”, “HIV infection WHO clinical stage III” and “HIV infection WHO clinical stage IV”.