Table 6.
|
QIV |
TIV-Vic |
TIV-Yam |
---|---|---|---|
N = 3036 | N = 1010 | N = 610 | |
Adverse events Day 0–20, n (%) |
|
|
|
Subjects with ≥ 1 event |
379 (12.5) |
138 (13.7) |
92 (15.1) |
Subjects with ≥ 1 Grade 3 event |
39 (1.3) |
7 (0.7) |
2 (0.3) |
Subjects with ≥ 1 event related to vaccination† |
64 (2.1) |
26 (2.6) |
14 (2.3) |
No. of events by MedDRA preferred term |
558 |
195 |
125 |
No. of Grade 3 events by MedDRA preferred term |
52 |
8 |
2 |
No. of events by MedDRA preferred term related to vaccination† |
89 |
38 |
16 |
Medically-attended adverse events Day 0–20, n (%) |
|
|
|
Subjects with ≥ 1 event |
193 (6.4) |
60 (5.9) |
47 (7.7) |
No. of events by MedDRA preferred term |
250 |
75 |
63 |
Medically-attended adverse events Day 0–180, n (%) |
|
|
|
Subjects with ≥ 1 event |
688 (22.7) |
216 (21.4) |
NA* |
No. of events by MedDRA preferred term | 1151 | 379 | NA* |
AE adverse event, MAE medically-attended adverse event, QIV inactivated quadrivalent influenza vaccine, TIV-Vic inactivated trivalent influenza vaccine Victoria lineage B strain, TIV-Yam inactivated trivalent influenza vaccine Yamagata lineage B strain, MedDRA Medical Dictionary for Regulatory Activities, NA not applicable, †Based on investigator’s assessment of causality; *TIV-YAM group was followed up until Day 21.