Table 3.
Incidence of any or grade 3 solicited injection site symptoms 21 days after DENV or control vaccination (total vaccinated cohort)
| Symptom | Type | Control group | 1/10 dose DENV cohort A | Full-dose DENV cohorts B and C | |||
|---|---|---|---|---|---|---|---|
| n | Percent (95% CI) | n | Percent (95% CI) | n | Percent (95% CI) | ||
| Dose 1 | N = 17 | N = 4 | N = 30 | ||||
| Pain | All | 3 | 17.6 (3.8–43.4) | 1 | 25.0 (0.6–80.6) | 11 | 36.7 (19.9–56.1) |
| Pain | Grade 3 | 0 | 0.0 (0.0–19.5) | 0 | 0.0 (0.0–60.2) | 0 | 0.0 (0.0–11.6) |
| Redness | All | 1 | 5.9 (0.1–28.7) | 2 | 50.0 (6.8–93.2) | 21 | 70.0 (50.6–85.3) |
| Redness | Grade 3 | 0 | 0.0 (0.0–19.5) | 0 | 0.0 (0.0–60.2) | 7 | 23.3 (9.9–42.3) |
| Swelling | All | 2 | 11.8 (1.5–36.4) | 1 | 25.0 (0.6–80.6) | 16 | 53.3 (34.3–71.7) |
| Swelling | Grade 3 | 0 | 0.0 (0.0–19.5) | 0 | 0.0 (0.0–60.2) | 3 | 10.0 (2.1–26.5) |
| Dose 2 | N = 16 | N = 4 | N = 30 | ||||
| Pain | All | 2 | 12.5 (1.6–38.3) | 1 | 25.0 (0.6–80.6) | 13 | 43.3 (25.5–62.6) |
| Pain | Grade 3 | 0 | 0.0 (0.0–20.6) | 0 | 0.0 (0.0–60.2) | 0 | 0.0 (0.0–11.6) |
| Redness | All | 3 | 18.8 (4.0–45.6) | 1 | 25.0 (0.6–80.6) | 13 | 43.3 (25.5–62.6) |
| Redness | Grade 3 | 0 | 0.0 (0.0–20.6) | 0 | 0.0 (0.0–60.2) | 6 | 20.0 (7.7–38.6) |
| Swelling | All | 1 | 6.3 (0.2–30.2) | 1 | 25.0 (0.6–80.6) | 8 | 26.7 (12.3–45.9) |
| Swelling | Grade 3 | 0 | 0.0 (0.0–20.6) | 0 | 0.0 (0.0–60.2) | 0 | 0.0 (0.0–11.6) |
Redness after dose 1: cohort A with two grade 1 symptoms and zero grade 2 symptoms; cohorts B and C with fifteen grade 1 symptoms and six with grade 2 symptoms. Swelling after dose 1: cohort A with one grade 1 symptom and zero grade 2 symptoms; cohorts B and C with fourteen grade 1 symptoms and two grade 2 symptoms. N = number of subjects having received at least one dose of either vaccine; n/% = number/percentage of subjects reporting a specified symptom; 95% CI (LL, UL) = 95% confidence interval (lower and upper limits).