TABLE 3. Number of participants (%) in the study reporting solicited systemic adverse events (AEs) occurring up to fourteen 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=296)b |
Any vaccination (N=99)a |
First vaccination (N=99) |
Second vaccination (N=94)b |
|
Any solicited systemic AE | ||||||
Anyc |
223 (74.6) |
202 (67.6) |
150 (50.7) |
67 (67.7) |
58 (58.6) |
43 (45.7) |
Mild |
127 (42.5) |
134 (44.8) |
93 (31.4) |
32 (32.3) |
32 (32.3) |
27 (28.7) |
Moderate |
67 (22.4) |
53 (17.7) |
38 (12.8) |
28 (28.3) |
22 (22.2) |
12 (12.8) |
Severe |
25 (8.4) |
12 (4.0) |
15 (5.1) |
7 (7.1) |
4 (4.0) |
4 (4.3) |
Headache | ||||||
Any |
170 (56.9) |
133 (44.5) |
105 (35.5) |
53 (53.5) |
44 (44.4) |
28 (29.8) |
Mild |
112 (37.5) |
94 (31.4) |
72 (24.3) |
28 (28.3) |
25 (25.3) |
19 (20.2) |
Moderate |
43 (14.4) |
31 (10.4) |
25 (8.4) |
22 (22.2) |
18 (18.2) |
6 (6.4) |
Severe |
15 (5.0) |
8 (2.7) |
8 (2.7) |
3 (3.0) |
1 (1.0) |
3 (3.2) |
Asthenia | ||||||
Any |
137 (45.8) |
104 (34.8) |
83 (28.0) |
44 (44.4) |
35 (35.4) |
26 (27.7) |
Mild |
92 (30.8) |
74 (24.7) |
59 (19.9) |
27 (27.3) |
20 (20.2) |
21 (22.3) |
Moderate |
35 (11.7) |
23 (7.7) |
20 (6.8) |
14 (14.1) |
13 (13.1) |
4 (4.3) |
Severe |
10 (3.3) |
7 (2.3) |
4 (1.4) |
3 (3.0) |
2 (2.0) |
1 (1.1) |
Malaise | ||||||
Any |
118 (39.5) |
83 (27.8) |
70 (23.6) |
42 (42.4) |
33 (33.3) |
22 (23.4) |
Mild |
73 (24.4) |
56 (18.7) |
48 (16.2) |
22 (22.2) |
20 (20.2) |
12 (12.8) |
Moderate |
34 (11.4) |
23 (7.7) |
15 (5.1) |
15 (15.2) |
11 (11.1) |
6 (6.4) |
Severe |
11 (3.7) |
4 (1.3) |
7 (2.4) |
5 (5.1) |
2 (2.0) |
4 (4.3) |
Muscle pain (myalgia) | ||||||
Any |
165 (55.2) |
143 (47.8) |
103 (34.8) |
50 (50.5) |
40 (40.4) |
29 (30.9) |
Mild |
112 (37.5) |
108 (36.1) |
76 (25.7) |
30 (30.3) |
26 (26.3) |
20 (21.3) |
Moderate |
44 (14.7) |
32 (10.7) |
20 (6.8) |
18 (18.2) |
13 (13.1) |
8 (8.5) |
Severe |
9 (3.0) |
3 (1.0) |
7 (2.4) |
2 (2.0) |
1 (1.0) |
1 (1.1) |
Fever (°C) | ||||||
Any |
38 (12.7) |
20 (6.7) |
20 (6.8) |
8 (8.1) |
5 (5.1) |
3 (3.2) |
38.0-<38.5 |
18 (6.0) |
9 (3.0) |
11 (3.7) |
4 (4.0) |
3 (3.0) |
1 (1.1) |
38.5-<39.0 |
13 (4.3) |
7 (2.3) |
6 (2.0) |
3 (3.0) |
2 (2.0) |
1 (1.1) |
39.0-<39.5 |
5 (1.7) |
3 (1.0) |
2 (0.7) |
1 (1.0) |
0 |
1 (1.1) |
39.5-<40.0 |
2 (0.7) |
1 (0.3) |
1 (0.3) |
0 |
0 |
0 |
“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
Fever is included in the “any” category but was not assessed by severity (mild/moderate/severe)
Source: Table prepared by the authors from current study data