Table 3.
Summary of solicited local adverse events within 7 days post vaccination (safety set).
| Number (%) of participants |
|||
|---|---|---|---|
| Adverse events | Any Vaccination (N = 200) |
First Vaccination (N = 200) |
Second Vaccination (N = 176) |
| Any solicited local adverse events | 89 (46.1) | 69 (35.9) | 54 (32.3) |
| N evaluated | 193 (96.5) | 192 (96.0) | 167 (94.9) |
| Mild | 74 (38.3) | 59 (30.7) | 48 (28.7) |
| Moderate | 12 (6.2) | 9 (4.7) | 4 (2.4) |
| Severe | 3 (1.6) | 1 (0.5) | 2 (1.2) |
| Pain | |||
| N evaluated | 193 (96.5) | 192 (96.0) | 167 (94.9) |
| Any event | 80 (41.5) | 57 (29.7) | 52 (31.1) |
| Mild | 67 (34.7) | 49 (25.5) | 46 (27.5) |
| Moderate | 10 (5.2) | 7 (3.6) | 4 (2.4) |
| Severe | 3 (1.6) | 1 (0.5) | 2 (1.2) |
| Erythemaa | |||
| N evaluated | 193 (96.5) | 192 (96.0) | 167 (94.9) |
| Any event | 29 (15.0) | 25 (13.0) | 10 (6.0) |
| Mild: ≥2.5-≤5 cm | 27 (14.0) | 23 (12.0) | 10 (6.0) |
| Moderate: >5-≤10 cm | 2 (1.0) | 2 (1.0) | 0 |
| Swellingb | |||
| N evaluated | 193 (96.5) | 192 (96.0) | 167 (94.9) |
| Any event | 9 (4.7) | 8 (4.2) | 4 (2.4) |
| Mild: ≥2.5-≤5 cm | 9 (4.7) | 8 (4.2) | 4 (2.4) |
aNo reported severe erythema events. bNo reported moderate or severe swelling events.
Any participant who experienced >1 adverse event is counted under each vaccine dose column, but is counted only once in the “Any vaccination” column.
All AEs were considered attributable to TAK-003 by default. Severity of each event was attributable according to pre-defined trial protocol criteria (see Table S2).
Pain, erythema, and swelling events were to be diary-recorded by each participant up to 7 days after each TAK-003 dose.