Table 5.
Proportion of subjects reporting solicited adverse events on Days 0–4
| Multi-dose Vial (Thimerosal-containing) N=823 | Pre-filled Syringe (Thimerosal-free) N=266 | Placebo N=268 | ||||
|---|---|---|---|---|---|---|
| Symptom | Any % (95% CI) | Severe % | Any % (95% CI) | Severe % | Any % (95% CI) | Severe % |
| Fever | 1.1 (0.5,2.1) |
0.0 | 1.5 (0.4,3.8) |
0.0 | 0.7 (<0.1,2.7) |
0.0 |
| Headache | 25.2 (22.2,28.3) |
0.2 | 27.1 (21.8,32.8) |
1.1 | 25.7 (20.6,31.4) |
0.4 |
| Malaise | 18.8 (16.2,21.7) |
0.1 | 21.4 (16.7,26.9) |
1.5 | 18.7 (14.2,23.8) |
0.4 |
| Myalgia | 12.2 (10.0,14.6) |
0.0 | 15** (11.0,19.9) |
0.8 | 9.0 (5.8,13.0) |
0.7 |
| Chills | 3.3 (2.2,4.7) |
0.0 | 2.3 (0.8,4.8) |
0.4 | 2.2 (0.8,4.8) |
0.0 |
| Nausea | 5.7 (4.2,7.5) |
0.2 | 8.6 (5.6,12.7) |
0.4 | 8.6 (5.5,12.6) |
0.4 |
| Vomiting | 0.9 (0.3,1.7) |
0.2 | 0.8 (<0.1,2.7) |
0.4 | 0.7 (<0.1,2.7) |
0.4 |
| Induration (swelling) | 10.0** (8.0,12.2) |
0.1 | 6.8** (4.1,10.5) |
1.1† | 0.7 (<0.1,2.7) |
0.0 |
| Erythema (redness) | 17.7** (15.2,20.5) |
0.2 | 12.0 (8.4,16.6) |
0.0‡ | 8.2 (5.2,12.2) |
0.0 |
| Vaccination site pain | 37.4** (34.1,40.8) |
0.0 | 47** (40.9,53.2) |
0.0 | 9.3 (6.1,13.5) |
0.0 |
| Tenderness | 57.1** (53.6,60.5) |
0.0 | 68** (62.1,73.6) |
0.0 | 17.9 (13.5,23.0) |
0.0 |
| Ecchymosis (bruising) | 5.1** (3.7,6.8) |
0.0 | 3.8 (1.8,6.8) |
0.0 | 1.1 (0.2,3.2) |
0.0 |
**
P <0.05 (P-values are from comparison of each vaccine to placebo.)
†
Severe induration is defined as > 50mm
‡
Severe eyrthema is defined as > 50mm