Table 3.
Percentage of subjects (with 95% confidence intervals) reporting solicited systemic symptoms within 7 days after the first and after the second dose of H1N1 vaccine in adults aged 18 to 60 years and in adults >60 years
| Symptom | Intensity |
Group A Vaccinated on Day 0 and Day 21 |
Group B Vaccinated on Day 0 and Day 182 |
||
|---|---|---|---|---|---|
|
Dose 1% (95% CI) | |||||
| 18-60 years N = 92 | >60 years N = 90 | 18-60 years N = 70 | >60 years N = 52 | ||
|
Fatigue |
Any |
43.5 |
28.9 |
38.6 |
34.6 |
| (33.2-54.2) |
(19.8-39.4) |
(27.2-51.0) |
(22.0-49.1) |
||
| Grade 3* |
0.0 |
0.0 |
1.4 |
0.0 |
|
| (0.0-3.9) |
(0.0-4.0) |
(0.0-7.7) |
(0.0-6.8) |
||
|
Headache |
Any |
37.0 |
22.2 |
31.4 |
17.3 |
| (27.1-47.7) |
(14.1-32.2) |
(20.9-43.6) |
(8.2-30.3) |
||
| Grade 3* |
0.0 |
1.1 |
1.4 |
0.0 |
|
| (0.0-3.9) |
(0.0-6.0) |
(0.0-7.7) |
(0.0-6.8) |
||
|
Joint pain at other location |
Any |
22.8 |
21.1 |
14.3 |
15.4 |
| (14.7-32.8) |
(13.2-31.0) |
(7.1-24.7) |
(6.9-28.1) |
||
| Grade 3* |
0.0 |
0.0 |
0.0 |
0.0 |
|
| (0.0-3.9) |
(0.0-4.0) |
(0.0-5.1) |
(0.0-6.8) |
||
|
Muscle aches |
Any |
46.7 |
28.9 |
32.9 |
28.8 |
| (36.3-57.4) |
(19.8-39.4) |
(22.1-45.1) |
(17.1-43.1) |
||
| Grade 3* |
0.0 |
0.0 |
0.0 |
1.9 |
|
| (0.0-3.9) |
(0.0-4.0) |
(0.0-5.1) |
(0.0-10.3) |
||
|
Shivering |
Any |
18.5 |
13.3 |
20.0 |
11.5 |
| (11.1-27.9) |
(7.1-22.1) |
(11.4-31.3) |
(4.4-23.4) |
||
| Grade 3* |
0.0 |
1.1 |
0.0 |
0.0 |
|
| (0.0-3.9) |
(0.0-6.0) |
(0.0-5.1) |
(0.0-6.8) |
||
|
Sweating |
Any |
13.0 |
11.1 |
10.0 |
13.5 |
| (6.9-21.7) |
(5.5-19.5) |
(4.1-19.5) |
(5.6-25.8) |
||
| Grade 3* |
1.1 |
0.0 |
0.0 |
0.0 |
|
| (0.0-5.9) |
(0.0-4.0) |
(0.0-5.1) |
(0.0-6.8) |
||
|
Fever (Axillary temp) |
Any |
1.1 |
1.1 |
2.9 |
1.9 |
| (0.0-5.9) |
(0.0-6.0) |
(0.3-9.9) |
(0.0-10.3) |
||
| ≥39.0 to ≤40°C |
0.0 |
0.0 |
0.0 |
0.0 |
|
| (0.0-3.9) |
(0.0-4.0) |
(0.0-5.1) |
(0.0-6.8) |
||
| |
|
Dose 2% (95% CI) |
|||
|
18-60 years N = 91 |
>60 years N = 85 |
18-60 years N = 60 |
>60 years N = 45 |
||
|
Fatigue |
Any |
53.8 |
31.8 |
51.7 |
29.5 |
| (43.1-64.4) |
(22.1-42.8) |
(38.4-64.8) |
(16.8-45.2) |
||
| Grade 3* |
3.3 |
1.2 |
3.3 |
0.0 |
|
| (0.7-9.3) |
(0.0-6.4) |
(0.4-11.5) |
(0.0-8.0) |
||
|
Headache |
Any |
45.1 |
22.4 |
35.0 |
25.0 |
| (34.6-55.8) |
(14.0-32.7) |
(23.1-48.4) |
(13.2-40.3) |
||
| Grade 3* |
1.1 |
1.2 |
5.0 |
0.0 |
|
| (0.0-6.0) |
(0.0-6.4) |
(1.0-13.9) |
(0.0-8.0) |
||
|
Joint pain at other location |
Any |
19.8 |
24.7 |
26.7 |
27.3 |
| (12.2-29.4) |
(16.0-35.3) |
(16.1-39.7) |
(15.0-42.8) |
||
| Grade 3* |
0.0 |
0.0 |
0.0 |
0.0 |
|
| (0.0-4.0) |
(0.0-4.2) |
(0.0-6.0) |
(0.0-8.0) |
||
|
Muscle aches |
Any |
42.9 |
29.4 |
51.7 |
34.1 |
| (32.5-53.7) |
(20.0-40.3) |
(38.4-64.8) |
(20.5-49.9) |
||
| Grade 3* |
0.0 |
0.0 |
1.7 |
0.0 |
|
| (0.0-4.0) |
(0.0-4.2) |
(0.0-8.9) |
(0.0-8.0) |
||
|
Shivering |
Any |
28.6 |
15.3 |
18.3 |
15.9 |
| (19.6-39.0) |
(8.4-24.7) |
(9.5-30.4) |
(6.6-30.1) |
||
| Grade 3* |
1.1 |
1.2 |
0.0 |
0.0 |
|
| (0.0-6.0) |
(0.0-6.4) |
(0.0-6.0) |
(0.0-8.0) |
||
|
Sweating |
Any |
20.9 |
16.5 |
13.3 |
9.1 |
| (13.1-30.7) |
(9.3-26.1) |
(5.9-24.6) |
(2.5-21.7) |
||
| Grade 3* |
1.1 |
0.0 |
0.0 |
0.0 |
|
| (0.0-6.0) |
(0.0-4.2) |
(0.0-6.0) |
(0.0-8.0) |
||
| Fever (Axillary temp) | Any |
6.6 |
5.9 |
1.7 |
0.0 |
| (2.5-13.8) |
(1.9-13.2) |
(0.0-8.9) |
(0.0-8.0) |
||
| ≥39.0 to ≤40°C |
0.0 |
2.4 |
0.0 |
0.0 |
|
| (0.0-4.0) | (0.3-8.2) | (0.0-6.0) | (0.0-8.0) | ||
*Grade 3 events were defined as events that prevent normal everyday activities (inability to attend/do work), or that require intervention of a physician/healthcare provider.