Table 5. Solicited local and systemic adverse events reported within five days of each vaccination in the Core Study and Booster Phase based on the safety population.
| Core Study n (%) [95% CI]a |
Booster Phase n (%) [95% CI]a |
||||||
|---|---|---|---|---|---|---|---|
| Adverse events |
Lot A n = 119 |
Lot B n = 120 |
Lot C n = 121 |
Pooled n = 360 |
Booster plus Rouvax (1 mo later) n = 110 |
Booster plus Rouvax (concomitantly) n = 105 |
Pooled n = 215 |
| Local |
|
|
|
|
|
|
|
| Induration |
21 (17.6) [11.3,25.7] |
29 (24.2) [16.8,32.8] |
31 (25.6) [18.1,34.4] |
81 (22.5) [18.3,27.2] |
24 (21.8) [14.5,30.7] |
25 (23.8) [16.0,33.1] |
49 (22.8) [17.4,29.0] |
| Systemic |
|
|
|
|
|
|
|
| ≥ 1 event reported |
96 (80.7) [72.4,87.3] |
96 (80.0) [71.7,86.7] |
83 (68.6) [59.5,76.7] |
275 (76.4) [71.7,80.7] |
66 (62.9) [52.9,72.1] |
52 (47.3) [37.7,57.0] |
118 (54.9) [48.0,61.7] |
| Feverb |
44 (37.0) [28.3,46.3] |
41(34.2) [28.8,43.4] |
38 (31.4) [23.3,40.5] |
123(34.2) [29.3,39.3] |
20 (19.0) [12.0,27.9] |
12 (10.9) [5.8,18.3] |
32 (14.9) [10.4,20.4] |
| Rash |
28 (23.5) [16.2,32.2] |
31 (25.8) [18.3,34.6] |
29 (24.0) [16.7,32.6] |
88(24.4) [20.1,29.2] |
4 (3.8) [1.0,9.5] |
5 (4.5) [1.5,10.3] |
9 (4.2) [18.6,30.5] |
| Change in eating habits |
28 (23.5) [16.2,32.2] |
32 (26.7) [19.0,35.5] |
34 (28.1) [20.3,37.0] |
94(26.1) [21.6,31.0] |
24 (22.9) [15.2,32.1] |
20 (18.2) [11.5,26.7] |
44 (20.5) [15.3,26.5] |
| Sleepiness |
47 (39.5) [30.7,48.9] |
45 (37.5) [28.8,46.8] |
44 (36.4) [27.8,45.6] |
136(37.8) [32.7,43.0] |
26 (24.8) [16.9,34.1] |
24 (21.8) [14.5,30.7] |
50 (23.3) [17.8,29.5] |
| Unusual crying |
55 (46.2) [37.0,55.6] |
59 (49.2) [39.9,58.4] |
51 (42.1) [33.2,51.5] |
165(45.8) [40.6,51.1] |
33 (31.4) [22.7,41.2] |
29 (26.4) [18.4,35.6] |
62 (28.8) [22.9,35.4] |
| Persistent crying |
13 (10.9) [5.9,18.0] |
11 (9.2) [4.7,15.8] |
10 (8.3) [4.0,14.7] |
34(9.4) [6.6,12.9] |
2 (1.9) [0.2,6.7] |
2 (1.8) [0.2,6.4] |
4 (21.4) [0.5,4.7] |
| Irritability |
42 (35.3) [26.8,44.6] |
39 (32.5) [24.2,41.7] |
34 (28.1) [20.3,37.0] |
115(31.9) [27.2,37.0] |
26 (24.8) [2.1,12.0] |
20 (18.2) [11.5,26.7] |
46 (21.4) [16.1,27.5] |
| Vomiting |
28 (23.5) [16.2,32.2] |
30 (25.0) [17.5,33.7] |
26 (21.5) [14.5,29.9] |
84(23.3) [19.1,28.1] |
6 (5.7) [2.1,12.0] |
2 (1.8) [0.2,6.4] |
8 (3.7) [1.6,7.2] |
| Diarrhea | 20 (16.8) [10.6,24.8] |
27 (22.5) [15.4,31.0] |
23 (19.0) [12.4,27.1] |
70(19.4) [15.5,23.9] |
6 (5.7) [2.1,12.0] |
6 (5.5) [2.0,11.5] |
12 (5.6) [2.9,9.5] |
a Values (%) based on number of infants experiencing an event/total number of infants receiving at least one injection (N). b Fever defined as body temperature ≥ 38.0°C. n = total number of infants receiving at least one injection (i.e., safety population). All local adverse events were considered vaccination-related; values for systemic adverse events represent all solicited adverse events reported, regardless of whether or not they were considered vaccination-related