Subsequent to publication of this paper errors in Table 5 (solicited local and systemic
adverse events…) have come to light. Below is the revised table.
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 AN = 119
Lot BN = 120
Lot CN = 121
PooledN = 360
Booster plus Rouvax (concomitantly) N = 105
Booster plus Rouvax (1 month later) N = 110
PooledN = 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]
25 (23.8)[16.0,33.1]
24 (21.8)[14.5,30.7]
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]
69 (65.7)[55.8,74.7]
60 (54.5)[44.8,64.1]
129 (60.0)[53.1,66.6]
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]
16 (14.5)[8.5,22.5]
36 (16.7)[12.0,22.4]
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]
5 (4.8)[1.6,10.8]
10 (9.1)[4.4,16.1]
15 (7.0)[4.0,11.2]
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]
30 (28.6)[20.2,38.2]
27 (24.5)[16.8,33.7]
57 (26.5)[20.7,32.9]
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]
29 (27.6)[19.3,37.2]
26 (23.6)[16.1,32.7]
55 (25.6)[19.9,32.0]
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]
35 (33.3)[24.4,43.2]
31 (28.2)[20.0,37.6]
66 (30.7)[24.6,37.3]
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 (1.9)[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]
28 (26.7)[18.5,36.2]
21 (19.1)[12.2,27.7]
49 (22.8)[17.4,29.0]
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]
10 (9.5)[4.7,16.8]
5 (4.5)[1.5,10.3]
15 (7.0)[4.0,11.2]
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]
8 (7.6)[3.3,14.5]
11 (10.0)[5.1,17.2]
19 (8.8)[5.4,13.5]
a Values (%) based on number of infants experiencing an event/total number of infants
receiving at least one injection (N). bFever 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