Table 3.
Summary of unsolicited AEs within 28 d after vaccine injection – Safety Analysis Set
| 60–64 y |
||||||||
|---|---|---|---|---|---|---|---|---|
| IIV4-HD |
IIV4-SD |
|||||||
| (N = 378) |
(N = 379) |
|||||||
| Participants experiencing at least one: | n | % | (95% CI) | No. of AEs | n | % | (95% CI) | No. of AEs |
| Immediate unsolicited AE | 1 | 0.3 | (0; 1.5) | 1 | 1 | 0.3 | (0; 1.5) | 1 |
| Immediate unsolicited AR | 1 | 0.3 | (0; 1.5) | 1 | 0 | 0 | (0; 1.0) | 0 |
| Unsolicited non-serious AE | 95 | 25.1 | (20.8; 29.8) | 144 | 100 | 26.4 | (22.0; 31.1) | 147 |
| Unsolicited non-serious AR | 25 | 6.6 | (4.3; 9.6) | 47 | 23 | 6.1 | (3.9; 9.0) | 33 |
| Unsolicited non-serious injection-site AR | 9 | 2.4 | (1.1; 4.5) | 10 | 8 | 2.1 | (0.9; 4.1) | 11 |
| Unsolicited non-serious systemic AE | 90 | 23.8 | (19.6; 28.4) | 134 | 96 | 25.3 | (21.0; 30.0) | 136 |
| Unsolicited non-serious systemic AR | 18 | 4.8 | (2.8; 7.4) | 37 | 17 | 4.5 | (2.6; 7.1) | 22 |
| SAE | 1 | 0.3 | (0; 1.5) | 1 | 2 | 0.5 | (0.1; 1.9) | 2 |
| AESI |
0 |
0 |
(0; 1.0) |
0 |
0 |
0 |
(0; 1.0) |
0 |
| ≥65 y |
||||||||
| IIV4-HD |
IIV4-SD |
|||||||
| (N = 394) |
(N = 382) |
|||||||
| Participants experiencing at least one: |
n |
% |
(95% CI) |
No. of AEs |
n |
% |
(95% CI) |
No. of AEs |
| Immediate unsolicited AE | 1 | 0.3 | (0; 1.4) | 1 | 0 | 0 | (0; 1.0) | 0 |
| Immediate unsolicited AR | 1 | 0.3 | (0; 1.4) | 1 | 0 | 0 | (0; 1.0) | 0 |
| Unsolicited non-serious AE | 91 | 23.1 | (19.0; 27.6) | 135 | 68 | 17.8 | (14.1; 22.0) | 96 |
| Unsolicited non-serious AR | 26 | 6.6 | (4.4; 9.5) | 32 | 16 | 4.2 | (2.4; 6.7) | 19 |
| Unsolicited non-serious injection-site AR | 8 | 2 | (0.9; 4.0) | 8 | 2 | 0.5 | (0.1; 1.9) | 2 |
| Unsolicited non-serious systemic AE | 84 | 21.3 | (17.4; 25.7) | 127 | 66 | 17.3 | (13.6; 21.4) | 94 |
| Unsolicited non-serious systemic AR | 18 | 4.6 | (2.7; 7.1) | 24 | 14 | 3.7 | (2.0; 6.1) | 17 |
| SAE | 4 | 1 | (0.3; 2.6) | 4 | 5 | 1.3 | (0.4; 3.0) | 5 |
| AESI | 0 | 0 | (0; 0.9) | 0 | 0 | 0 | (0; 1.0) | 0 |
n: number of participants experiencing the endpoint listed in the first column.
N: number of participants with available data for the relevant endpoint.
“AE leading to study discontinuation” includes those participants meeting at least one of the two following criteria:
1. Termination form marked “not completed” due to “adverse event”
2. Any AE of at least Grade 1 within the time period (missing intensity is included) marked “caused study termination/discontinuation.”
Unsolicited non-serious systemic AEs (including SAEs) within 30 min are considered immediate.
Missing relationship (for the definition of AR) was considered at the time of analysis as related to the vaccine.
AE, adverse event; AESI, adverse event of special interest; AR, adverse reaction; IIV4-HD, quadrivalent high-dose inactivated influenza vaccine; IIV4-SD, standard-dose quadrivalent influenza vaccine; SAE, serious adverse event.