Overall Summary of Solicited and Unsolicited Adverse Events in Subjects 6 Through 47 Months of Age (Full Analysis Set)
| Adverse Event, n (%)a . | US-Licensed QIV, n (%) (n = 805) . | QIVc, n (%) (n = 1597) . |
|---|---|---|
| Solicited | ||
| Any | 517 (65.9) | 997 (63.7) |
| Local | 350 (44.6) | 656 (41.9) |
| Systemic | 358 (45.7) | 681 (43.5) |
| Analgesic or antipyretic use | 136 (17.3) | 240 (15.3) |
| Unsolicited | ||
| Any | 207 (25.7) | 418 (26.2) |
| Mild | 164 (20.4) | 308 (19.3) |
| Moderate | 41 (5.1) | 98 (6.1) |
| Severe | 2 (0.2) | 12 (0.8) |
| Any related | 36 (4.5) | 70 (4.4) |
| Any SAE | 7 (0.9) | 15 (0.9) |
| Related SAE | 0 | 0 |
| Deaths | 0 | 2 (0.1) |
| New onset chronic disease | 13 (1.6) | 22 (1.4) |
| AE leading to study withdrawal | 0 | 3 (0.2) |
| Medically attended AE | 97 (12.0) | 222 (13.9) |
| Adverse Event, n (%)a . | US-Licensed QIV, n (%) (n = 805) . | QIVc, n (%) (n = 1597) . |
|---|---|---|
| Solicited | ||
| Any | 517 (65.9) | 997 (63.7) |
| Local | 350 (44.6) | 656 (41.9) |
| Systemic | 358 (45.7) | 681 (43.5) |
| Analgesic or antipyretic use | 136 (17.3) | 240 (15.3) |
| Unsolicited | ||
| Any | 207 (25.7) | 418 (26.2) |
| Mild | 164 (20.4) | 308 (19.3) |
| Moderate | 41 (5.1) | 98 (6.1) |
| Severe | 2 (0.2) | 12 (0.8) |
| Any related | 36 (4.5) | 70 (4.4) |
| Any SAE | 7 (0.9) | 15 (0.9) |
| Related SAE | 0 | 0 |
| Deaths | 0 | 2 (0.1) |
| New onset chronic disease | 13 (1.6) | 22 (1.4) |
| AE leading to study withdrawal | 0 | 3 (0.2) |
| Medically attended AE | 97 (12.0) | 222 (13.9) |
AE, adverse event; QIV, US-licensed quadrivalent inactivated influenza vaccine; QIVc, cell-derived quadrivalent inactivated influenza vaccine; SAE, serious adverse event.
Data are descriptive in nature and no formal statistical comparisons were done.