Table 3.
Number and percentage of subjects with solicited injection site reactions reported during the 21-day (days 0–20) postvaccination periods (TVC)
| Injection site reaction | F17 N = 207 | F19 N = 211 | Placebo N = 210 | ||||
|---|---|---|---|---|---|---|---|
| Type | n | (95% CI) | n | (95% CI) | n | (95% CI) | |
| Pain | All | 44 | 21.3 (15.9, 27.5) | 53 | 25.1 (19.4, 31.5) | 41 | 19.5 (14.4, 25.5) |
| Grade 3 | 1 | 0.5 (0.0, 2.7) | 0 | 0.0 (0.0, 1.7) | 0 | 0.0 (0.0, 1.7) | |
| Redness | All | 23 | 11.1 (7.2, 16.2) | 20 | 9.5 (5.9, 14.3) | 16 | 7.6 (4.4, 12.1) |
| Grade 3 | 5 | 2.4 (0.8, 5.5) | 2 | 0.9 (0.1, 3.4) | 4 | 1.9 (0.5, 4.8) | |
| Swelling | All | 16 | 7.7 (4.5, 12.2) | 13 | 6.2 (3.3, 10.3) | 9 | 4.3 (2.0, 8.0) |
| Grade 3 | 3 | 1.4 (0.3, 4.2) | 0 | 0.0 (0.0, 1.7) | 1 | 0.5 (0.0, 2.6) | |
All = any intensity of injection site reaction; 95% CI = exact 95% confidence interval (lower and upper limit); Grade 3 pain = pain that prevented normal, everyday activities; Grade 3 redness/swelling = diameter of redness/swelling > 20 mm; N = number of subjects with at least one dose injected and accompanied by a completed diary card; n/% = number/percentage of subjects reporting the injection site reaction; TVC = total vaccinated cohort.