Table 4.
Solicited Local and Systemic Adverse Events After the First, Second, and Any Vaccination Dose for Participants Aged 4–60 Years (Placebo-Controlled Trials Safety Pool, Safety Set)
| AE | Participants, No. With AE/Total No. With Data | |
|---|---|---|
| TAK-003 (n = 3830a) | Placebo (n = 1725a) | |
| Solicited local AEs within 7 days after dose | ||
| ȃAfter 1st vaccination | ||
| ȃȃAny solicited local AE | 1290/3747 (34.4) | 327/1690 (19.3) |
| ȃȃPain | 1220/3747 (32.6) | 324/1690 (19.2) |
| ȃȃErythema | 218/3729 (5.8) | 3/1680 (0.2) |
| ȃȃSwelling | 98/3723 (2.6) | 8/1680 (0.5) |
| ȃAfter 2nd vaccination | ||
| ȃȃAny solicited local AE | 1056/3654 (28.9) | 222/1647 (13.5) |
| ȃȃPain | 1000/3652 (27.4) | 220/1646 (13.4) |
| ȃȃErythema | 157/3642 (4.3) | 2/1642 (0.1) |
| ȃȃSwelling | 59/3637 (1.6) | 3/1638 (0.2) |
| ȃAfter any vaccination | ||
| ȃȃAny solicited local AE | 1642/3782 (43.4) | 437/1703 (25.7) |
| ȃȃPain | 1581/3782 (41.8) | 432/1703 (25.4) |
| ȃȃErythema | 268/3781 (7.1) | 5/1702 (0.3) |
| ȃȃSwelling | 130/3780 (3.4) | 11/1702 (0.6) |
| Solicited systemic AE within 14 days after dose | ||
| ȃAfter 1st vaccination | ||
| ȃȃAny solicited systemic AE, excluding fever | 1360/3749 (36.3) | 519/1690 (30.7) |
| ȃȃHeadache | 922/3406 (27.1) | 370/1512 (24.5) |
| ȃȃMyalgia | 747/3405 (21.9) | 239/1512 (15.8) |
| ȃȃMalaise | 571/3404 (16.8) | 216/1419 (15.2) |
| ȃȃAsthenia | 490/3406 (14.4) | 189/1418 (13.3) |
| ȃȃIrritability/fussinessb | 30/341 (8.8) | 15/177 (8.5) |
| ȃȃDrowsinessb | 36/341 (10.6) | 18/177 (10.2) |
| ȃȃLoss of appetiteb | 47/341 (13.8) | 16/177 (9.0) |
| ȃȃFever (≥38°C) | 189/3517 (5.4) | 97/1577 (6.2) |
| ȃAfter 2nd vaccination | ||
| ȃȃAny solicited systemic AE, excluding fever | 924/3649 (25.3) | 324/1646 (19.7) |
| ȃȃHeadache | 600/3350 (17.9) | 229/1494 (15.3) |
| ȃȃMyalgia | 532/3349 (15.9) | 154/1494 (10.3) |
| ȃȃMalaise | 402/3349 (12.0) | 142/1402 (10.1) |
| ȃȃAsthenia | 355/3349 (10.6) | 123/1402 (8.8) |
| ȃȃIrritability/fussinessb | 18/299 (6.0) | 4/152 (2.6) |
| ȃȃDrowsinessb | 21/299 (7.0) | 7/152 (4.6) |
| ȃȃLoss of appetiteb | 22/299 (7.4) | 9/152 (5.9) |
| ȃȃFever (≥38°C) | 157/3520 (4.5) | 90/1573 (5.7) |
| ȃAfter any vaccination | ||
| ȃȃAny solicited systemic AEs, excluding fever | 1655/3782 (43.8) | 632/1702 (37.1) |
| ȃȃHeadache | 1176/3476 (33.8) | 465/1545 (30.1) |
| ȃȃMyalgia | 973/3476 (28.0) | 316/1545 (20.5) |
| ȃȃMalaise | 795/3475 (22.9) | 300/1451 (20.7) |
| ȃȃAsthenia | 684/3476 (19.7) | 254/1451 (17.5) |
| ȃȃIrritability/fussinessb | 43/348 (12.4) | 17/178 (9.6) |
| ȃȃDrowsinessb | 46/348 (13.2) | 22/178 (12.4) |
| ȃȃLoss of appetiteb | 59/348 (17.0) | 22/178 (12.4) |
| ȃȃFever (≥38°C) | 331/3704 (8.9) | 175/1667 (10.5) |
Abbreviation: AE, adverse event.
Solicited AEs were recorded for a randomly selected subset of participants from DEN-301 and DEN-204. bAssessed only for those participants aged <6 years.