Table 2.
Number and percentage of subjects reporting injection site reactions during the 21-day follow-up period post-vaccination (total vaccinated cohort)
| Injection site | F17 (N = 40) | F19 (N = 39) | Placebo (N = 40) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Reactions | Type | n | % | 95% CI | n | % | 95% CI | n | % | 95% CI |
| Both doses/subject | ||||||||||
| Pain | All | 19 | 47.5 | 31.5–63.9 | 10 | 25.6 | 13.0–42.1 | 10 | 25.0 | 12.7–41.2 |
| Redness | All | 16 | 40.0 | 24.9–56.7 | 15 | 38.5 | 23.4–55.4 | 9 | 22.5 | 10.8–38.5 |
| Swelling | All | 9 | 22.5 | 10.8–38.5 | 6 | 15.4 | 5.9–30.5 | 5 | 12.5 | 4.2–26.8 |
| Dose 1 | ||||||||||
| Pain | All | 14 | 35.0 | 20.6–51.7 | 6 | 15.4 | 5.9–30.5 | 6 | 15.0 | 5.7–29.8 |
| Redness | All | 12 | 30.0 | 16.6–46.5 | 11 | 28.2 | 15.0–44.9 | 8 | 20.0 | 9.1–35.6 |
| Swelling | All | 5 | 12.5 | 4.2–26.8 | 4 | 10.3 | 2.9–24.2 | 2 | 5.0 | 0.6–16.9 |
| Dose 2 | ||||||||||
| Pain | All | 13 | 33.3 | 19.1–50.2 | 7 | 20.0 | 8.4–36.9 | 6 | 15.4 | 5.9–30.5 |
| Redness | All | 13 | 33.3 | 19.1–50.2 | 8 | 22.9 | 10.4–40.1 | 6 | 15.4 | 5.9–30.5 |
| Swelling | All | 7 | 17.9 | 7.5–33.5 | 4 | 11.4 | 3.2–26.7 | 5 | 12.8 | 4.3–27.4 |
All = includes all grades (1–3) reported; N = number of subjects with at least one documented dose; n/% = number/percentage of subjects reporting the symptom at least one time; No grade 3 injection site reaction reported; 95% CI = exact 95% confidence interval.