Table 1.
Incidence of adverse events (solicited and unsolicited) reported during the 7-D (D 0–6) post-vaccination period following DPIV+AS03B and placebo doses (TVC)
| Any grade | Any grade related* | Grade 3 | Grade 3 related* | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Group | N | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| DPIV+AS03B dose 1 | 0–1 M | 35 | 26 | 74.3 (56.7–87.5) | 26 | 74.3 (56.7–87.5) | 0 | 0.0 (0.0–10.0) | 0 | 0.0 (0.0–10.0) |
| 0–1–6 M | 35 | 25 | 71.4 (53.7–85.4) | 25 | 71.4 (53.7–85.4) | 0 | 0.0 (0.0–10.0) | 0 | 0.0 (0.0–10.0) | |
| 0–1 M/0–1–6 M | 70 | 51 | 72.9 (60.9–82.8) | 51 | 72.9 (60.9–82.8) | 0 | 0.0 (0.0–5.1) | 0 | 0.0 (0.0–5.1) | |
| 0–3 M | 67 | 38 | 56.7 (44.0–68.8) | 33 | 49.3 (36.8–61.8) | 4 | 6.0 (1.7–14.6) | 2 | 3.0 (0.4–10.4) | |
| DPIV+AS03B dose 2 | 0–1 M | 34 | 19 | 55.9 (37.9–72.8) | 19 | 55.9 (37.9–72.8) | 3 | 8.8 (1.9–23.7) | 2 | 5.9 (0.7–19.7) |
| 0–1–6 M | 33 | 22 | 66.7 (48.2–82.0) | 17 | 51.5 (33.5–69.2) | 1 | 3.0 (0.1–15.8) | 1 | 3.0 (0.1–15.8) | |
| 0–1 M/0–1–6 M | 67 | 41 | 61.2 (48.5–72.9) | 36 | 53.7 (41.1–66.0) | 4 | 6.0 (1.7–14.6) | 3 | 4.5 (0.9–12.5) | |
| 0–3 M | 65 | 38 | 58.5 (45.6–70.6) | 30 | 46.2 (33.7–59.0) | 2 | 3.1 (0.4–10.7) | 1 | 1.5 (0.0–8.3) | |
| DPIV+AS03B dose 3 | 0–1–6 M | 32 | 19 | 59.4 (40.6–76.3) | 18 | 56.3 (37.7–73.6) | 2 | 6.3 (0.8–20.8) | 2 | 6.3 (0.8–20.8) |
| Overall/DPIV+AS03B dose | 0–1 M | 69 | 45 | 65.2 (52.8–76.3) | 45 | 65.2 (52.8–76.3) | 3 | 4.3 (0.9–12.2) | 2 | 2.9 (0.4–10.1) |
| 0–1–6 M | 100 | 66 | 66.0 (55.8–75.2) | 60 | 60.0 (49.7–69.7) | 3 | 3.0 (0.6–8.5) | 3 | 3.0 (0.6–8.5) | |
| 0–1 M/0–1–6 M | 137 | 92 | 67.2 (58.6–74.9) | 87 | 63.5 (54.9–71.6) | 4 | 2.9 (0.8–7.3) | 3 | 2.2 (0.5–6.3) | |
| 0–3 M | 132 | 76 | 57.6 (48.7–66.1) | 63 | 47.7 (39.0–56.6) | 6 | 4.5 (1.7–9.6) | 3 | 2.3 (0.5–6.5) | |
| Overall/placebo dose | 0–1 M | 64 | 26 | 40.6 (28.5–53.6) | 18 | 28.1 (17.6–40.8) | 1 | 1.6 (0.0–8.4) | 0 | – |
| 0–1–6 M | 34 | 16 | 47.1 (29.8–64.9) | 8 | 23.5 (10.7–41.2) | 1 | 2.9 (0.1–15.3) | 0 | – | |
| 0–1 M/0–1–6 M | 67 | 30 | 44.8 (32.6–57.4) | 18 | 26.9 (16.8–39.1) | 1 | 1.5 (0.0–8.0) | 0 | – | |
| 0–3 M | 140 | 56 | 40.0 (31.8–48.6) | 36 | 25.7 (18.7–33.8) | 3 | 2.1 (0.4–6.1) | 0 | – | |
DPIV+AS03B = adjuvant system 03B-adjuvanted inactivated tetravalent dengue virus vaccine; M= month; N = number of patients with at least one documented dose/documented doses; n/% = number/percentage of patients/doses followed by at least one type of symptom whatever the study vaccine administered; TVC = total vaccinated cohort; 0–1 M = participants receiving two doses of DPIV+AS03B administered 1 M apart, at M0 and M1; 0–3 M = participants receiving two doses of DPIV+AS03B administered 3 M apart, at M3 and M6; 0–1–6 M = participants receiving three doses of DPIV+AS03B with the first two given 1 M apart and the third given 6 M after the first, at M0, M1, and M6; 0–1 M/0–1–6 M = pooled group.
Causal relationship to vaccination was assessed by the investigator.