Table 5.
Incidence of TIV reactogenicity events from Day 0† to Day 3 in the Safety Set
| Symptom | TIV N = 3783 n (%) |
Placebo N = 3828 n (%) |
P-value¶ |
|---|---|---|---|
| At least 1 vaccine reactogenicity event | 2487 (66) | 1675 (44) | <0.0001 |
| Fever‡ | 96 (3) | 55 (1) | 0.0005 |
| Injection site pain/soreness | 1933 (51) | 530 (14) | <0.0001 |
| Injection site redness | 475 (13) | 234 (6) | <0.0001 |
| Injection site swelling | 418 (11) | 109 (3) | <0.0001 |
| Myalgia and/or arthralgia | 692 (18) | 389 (10) | <0.0001 |
| Headache | 683 (18) | 716 (19) | 0.5491 |
| Tiredness | 761 (20) | 678 (18) | 0.0049 |
| Chills | 158 (4) | 136 (4) | 0.1526 |
| Malaise | 338 (9) | 236 (6) | <0.0001 |
| Red eyes | 250 (7) | 231 (6) | 0.2772 |
| Swelling of the face | 51 (1) | 37 (<1) | 0.1327 |
| Cough | 286 (8) | 250 (7) | 0.0719 |
| Chest tightness or difficulty in breathing | 128 (3) | 107 (3) | 0.1274 |
| Sore throat, hoarseness or pain on swallowing | 324 (9) | 344 (9) | 0.5689 |
†>30 minutes post-vaccination
¶Fisher's Exact test (p < 0.05 considered significant)
‡Temperature ≥37.5°C/99.5°F