Table 2.
Incidence of unsolicited adverse events within the 28-D (D 0–27) post-vaccination period following DPIV+AS03B and placebo doses (TVC)
| 0–1 M (N = 35) | 0–1–6 M (N = 35) | 0–1 M/0–1–6 M (N = 70) | 0–3 M (N = 68) | |||||
|---|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| DPIV+AS03B | ||||||||
| Any | 15 | 42.9 (26.3–60.6) | 22 | 62.9 (44.9–78.5) | 31 | 44.3 (32.4–56.7) | 31 | 45.6 (33.5–58.1) |
| Grade 3 | 1 | 2.9 (0.1–14.9) | 0 | 0.0 (0.0–10.0) | 1 | 1.4 (0.0–7.7) | 0 | 0.0 (0.0–5.3) |
| Related* | 3 | 8.6 (1.8–23.1) | 2 | 5.7 (0.7–19.2) | 5 | 7.1 (2.4–15.9) | 3 | 4.4 (0.9–12.4) |
| Placebo | ||||||||
| Any | 12 | 35.3 (19.7–53.5) | 10 | 29.4 (15.1–47.5) | 18 | 26.5 (16.5–38.6) | 33 | 47.1 (35.1–59.4) |
DPIV+AS03B = adjuvant system 03B-adjuvanted inactivated tetravalent dengue virus vaccine; M = month; N = number of participants with at least one administered dose; n/%, number/percentage of participants reporting a symptom at least once; 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 (0–1 M)/(0–1–6 M).
Causal relationship to vaccination was assessed by the investigator.