Table 4.
Reenrolled Study Participants With Serious Adverse Events
| Event | Vaccination Patterna |
||||
|---|---|---|---|---|---|
| Y1 IIV-HD, Y2 IIV-HD (n = 1942) | Y1 IIV-SD, Y2 IIV-HD (n = 1881) | Y1 IIV-HD or -SD, Y2 IIV-HD (n = 3823) | Y1 IIV-HD, Y2 IIV-SD (n = 1891) | Y1 IIV-SD, Y2 IIV-SD (n = 1929) | |
| Subjects with SAEs within 30 d of Y2 vaccination | |||||
| Any SAE | 29 (1.5) | 15 (0.8) | 44 (1.2) | 12 (0.6) | 27 (1.4) |
| Death | 0 (0.0) | 1 (0.1) | 1 (0.0) | 0 (0.0) | 0 (0.0) |
| Pneumonia | 0 (0.0) | 3 (0.2) | 3 (0.1) | 3 (0.2) | 0 (0.0) |
| Hospitalization | 27 (1.4) | 13 (0.7) | 40 (1.0) | 11 (0.6) | 25 (1.3) |
| Subjects with SAEs within 180 d of Y2 vaccination | |||||
| Any SAE | 128 (6.6) | 122 (6.5) | 250 (6.5) | 141 (7.5) | 140 (7.3) |
| Death | 2 (0.1) | 7 (0.4) | 9 (0.2) | 6 (0.3) | 6 (0.3) |
| Pneumonia | 6 (0.3) | 8 (0.4) | 14 (0.4) | 16 (0.8) | 12 (0.6) |
| Hospitalization | 118 (6.1) | 113 (6.0) | 231 (6.0) | 134 (7.1) | 132 (6.8) |
Data are presented as No. (%).
Abbreviations: IIV-HD, high-dose inactivated influenza vaccine; IIV-SD, standard-dose inactivated influenza vaccine; SAE, serious adverse event; Y1, year 1; Y2, year 2.
a Based on vaccines actually received in year 1 and year 2.