Table 4 Global summary of unsolicited adverse events in adults, children, and infants in the total vaccinated cohort
Infants | Children | Adults | ||||
|---|---|---|---|---|---|---|
6–35 months | 3–17 years | 18–49 years | ||||
IIV4-I N = 466 | IIV4 N = 474 | IIV4-I N = 410 | IIV4 N = 411 | IIV4-I N = 60 | IIV4 N = 60 | |
Unsolicited AEs for 21 days (adults) or 28 days (infants & children) post-last vaccination | ||||||
≥1 AE, n (%) | 243 (52.1) | 262 (55.3) | 83 (20.2) | 86 (20.9) | 14 (23.3) | 14 (23.3) |
≥1 Grade 3 AE, n (%) | 33 (7.1) | 31 (6.5) | 12 (2.9) | 8 (1.9) | 3 (5.0) | 2 (3.3) |
≥1 AE causally-related to vaccination, n (%) | 6 (1.3) | 3 (0.6) | 10 (2.4) | 7 (1.7) | 2 (3.3) | 1(1.7) |
≥1 Grade 3 AE causally-related to vaccination, n (%) | 1 (0.2) [bronchitis] | 0 | 1 (0.2) [axillary pain] | 1 (0.2) [injection site pustule] | 0 | 0 |
MAEs for entire studya | ||||||
≥1 MAE, n (%) | 235 (50.4) | 252 (53.2) | 59 (14.4) | 52 (12.7) | 9 (15.0) | 8 (13.3) |
≥1 Grade 3 MAE, n (%) | 35 (7.5) | 29 (6.1) | 7 (1.7) | 6 (1.5) | 3 (5.0) | 1 (1.7) |
≥1 MAE causally-related to vaccination, n (%) | 2 (0.4) | 0 | 2 (0.5) | 0 | 0 | 0 |
≥1 Grade 3 MAE causally-related to vaccination, n (%) | 1 (0.2) [bronchitis] | 0 | 0 | 0 | 0 | 0 |
SAEs for entire studya | ||||||
≥1 SAE, n (%) | 7 (1.5) | 11 (2.3) | 1 (0.2) | 0 | 1 (1.7) | 1 (1.7) |
≥1 SAE causally-related to vaccination, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |