TABLE 2. Number of participants (%) in the study reporting solicited local adverse events (AEs) occurring up to seven days after each vaccination at Months 0 and 3. Safety set data.
AE severity |
TAK-003 |
Placebo |
||||
|---|---|---|---|---|---|---|
|
Any vaccination (n=299)a |
First vaccination (n=299) |
Second vaccination (n=295)b |
Any vaccination (n=99)a |
First vaccination (n=99) |
Second vaccination (n=94)b |
|
Any solicited local AE | ||||||
Any |
212 (70.9) |
168 (56.2) |
154 (52.2) |
49 (49.5) |
34 (34.3) |
29 (30.9) |
Mild |
145 (48.5) |
137 (45.8) |
106 (35.9) |
37 (37.4) |
26 (26.3) |
23 (24.5) |
Moderate |
56 (18.7) |
29 (9.7) |
39 (13.2) |
10 (10.1) |
7 (7.1) |
5 (5.3) |
Severe |
11 (3.7) |
2 (0.7) |
9 (3.1) |
2 (2.0) |
1 (1.0) |
1 (1.1) |
Pain | ||||||
Any |
210 (70.2) |
165 (55.2) |
153 (51.9) |
49 (49.5) |
34 (34.3) |
29 (30.9) |
Mild |
143 (47.8) |
134 (44.8) |
105 (35.6) |
37 (37.4) |
26 (26.3) |
23 (24.5) |
Moderate |
56 (18.7) |
29 (9.7) |
39 (13.2) |
10 (10.1) |
7 (7.1) |
5 (5.3) |
Severe |
11 (3.7) |
2 (0.7) |
9 (3.1) |
2 (2.0) |
1 (1.0) |
1 (1.1) |
Erythema | ||||||
Any |
25 (8.4) |
17 (5.7) |
12 (4.1) |
0 |
0 |
0 |
Mild: 2.5-5 cm |
25 (8.4) |
17 (5.7) |
12 (4.1) |
0 |
0 |
0 |
Swelling | ||||||
Any |
17 (5.7) |
13 (4.3) |
6 (2.0) |
0 |
0 |
0 |
Mild: 2.5-5 cm |
16 (5.4) |
13 (4.3) |
5 (1.7) |
0 |
0 |
0 |
Moderate: >5-≤10 cm |
1 (0.3) |
0 |
1 (0.3) |
0 |
0 |
0 |
Severity categories are excluded from the table if no participants in either study group experienced AEs after either of the vaccinations
“Any vaccination” refers to the number of participants reporting AEs after either of the vaccinations
One participant in each study group did not provide a diary card
Only includes participants who received the second vaccination and provided completed diary cards
Source: Table prepared by the authors from current study data