| |
Group A* (N= 188) |
Group B* (N= 94) |
Group C* (N= 188) |
|
Severity |
n/N |
% |
[95% CI] |
n/N |
% |
[95% CI] |
n/N |
% |
[95% CI] |
| Injection site reactions |
|
|
|
|
|
|
|
|
|
|
| Tenderness† |
Any |
40/182 |
22.0 |
[16.2;28.7] |
20/88 |
22.7 |
[14.5;32.9] |
48/177 |
27.1 |
[20.7;34.3] |
| |
Grade 3 |
2/182 |
1.1 |
[0.1;3.9] |
0/88 |
0.0 |
[0.0;4.1] |
4/177 |
2.3 |
[0.6;5.7] |
| Erythema† |
Any |
14/182 |
7.7 |
[4.3;12.6] |
7/88 |
8.0 |
[3.3;15.7] |
26/177 |
14.7 |
[9.8;20.8] |
| |
Grade 3 |
0/182 |
0.0 |
[0.0;2.0] |
0/88 |
0.0 |
[0.0;4.1] |
0/177 |
0.0 |
[0.0;2.1] |
| Swelling† |
Any |
10/182 |
5.5 |
[2.7;9.9] |
5/88 |
5.7 |
[1.9;12.8] |
15/177 |
8.5 |
[4.8;13.6] |
| |
Grade 3 |
0/182 |
0.0 |
[0.0;2.0] |
0/88 |
0.0 |
[0.0;4.1] |
0/177 |
0.0 |
[0.0;2.1] |
| Systemic reactions |
|
|
|
|
|
|
|
|
|
|
| Fever |
Any |
11/182 |
6.0 |
[3.1;10.6] |
8/88 |
9.1 |
[4.0;17.1] |
22/177 |
12.4 |
[8.0;18.2] |
| |
Grade 3 |
0/182 |
0.0 |
[0.0;2.0] |
1/88 |
1.1 |
[0.0;6.2] |
0/177 |
0.0 |
[0.0;2.1] |
| Vomiting |
Any |
31/182 |
17.0 |
[11.9;23.3] |
19/88 |
21.6 |
[13.5;31.6] |
42/177 |
23.7 |
[17.7;30.7] |
| |
Grade 3 |
1/182 |
0.5 |
[0.0;3.0] |
1/88 |
1.1 |
[0.0;6.2] |
2/177 |
1.1 |
[0.1;4.0] |
| Abnormal crying |
Any |
47/182 |
25.8 |
[19.6;32.8] |
30/88 |
34.1 |
[24.3;45.0] |
58/177 |
32.8 |
[25.9;40.2] |
| |
Grade 3 |
4/182 |
2.2 |
[0.6;5.5] |
0/88 |
0.0 |
[0.0;4.1] |
6/177 |
3.4 |
[1.3;7.2] |
| Drowsiness |
Any |
24/182 |
13.2 |
[8.6;19.0] |
14/88 |
15.9 |
[9.0;25.2] |
36/177 |
20.3 |
[14.7;27.0] |
| |
Grade 3 |
0/182 |
0.0 |
[0.0;2.0] |
0/88 |
0.0 |
[0.0;4.1] |
0/177 |
0.0 |
[0.0;2.1] |
| Appetite lost |
Any |
62/182 |
34.1 |
[27.2;41.4] |
28/88 |
31.8 |
[22.3;42.6] |
73/177 |
41.2 |
[33.9;48.9] |
| |
Grade 3 |
7/182 |
3.8 |
[1.6;7.8] |
9/88 |
10.2 |
[4.8;18.5] |
12/177 |
6.8 |
[3.6;11.5] |
| Irritability |
Any |
83/182 |
45.6 |
[38.2;53.1] |
47/88 |
53.4 |
[42.5;64.1] |
91/177 |
51.4 |
[43.8;59.0] |
| |
Grade 3 |
9/182 |
4.9 |
[2.3;9.2] |
7/88 |
8.0 |
[3.3;15.7] |
14/177 |
7.9 |
[4.4;12.9] |
* Group A: HAV on Day 0 + MMR vaccine on Day 28; Group B: MMR vaccine on Day 0 + HAV on Day 28; Group C: HAV and MMR vaccine on Day 0. All groups received
a booster dose of HAV on Day 213
† after at least one of the two vaccinations for Group C
Note: All solicited events are considered as reactions. For solicited reactions, the denominator for percentages is the number of vaccinated subjects for those at least one
safety record for the concerned solicited reaction is available. Each subject is counted once and classified in the highest recorded severity score for the concerned solicited
reactio
Grade 1, 2, and 3 pain were defined as ‘minor reaction when injection site is touched,’ ‘cries and protests when injection site is touched,’ and ‘cries when injected limb is
moved or the movement of the injected limb is reduced.’ For erythema and swelling, a diameter of <2.5 cm was assessed as Grade 1, from 2.5 to <5 cm as Grade 2 and
≥5 cm as Grade 3. Grade 1, 2, and 3 fever were defined as temperature ≥38.0°C–≤38.5°C, >38.5°C–≤39.0°C, and >39.5°C, respectively. Other systemic symptoms were
defined as: vomiting (Grade 1-Grade 2, 1 to 5 episodes/day; Grade 3, ≥6 episodes /day) abnormal crying (Grade 1-Grade 2, ≤3 hours; Grade 3, >3 hours), drowsiness,
(Grade 1-Grade 2, unusually sleepy; Grade 3, sleepy most of the time) loss of appetite (Grade 1-Grade 2, missed 1 to 2 meals; Grade 3, missed ≥3 meals) and irritability
(Grade 1-Grade 2, easily consolable or needs increased attention; Grade 3, inconsolable) |
