Table 3. Comparison of IMVAMUNE®/ACAM2000™/Dryvax® adverse events (possibly related) occurring in at least 5% of trial subjects.
|
Adverse event characterization
|
Vaccinia-naive subjects
|
||
|---|---|---|---|
| Preferred term | IMVAMUNE (n = 1025) (n; %)* | ACAM2000 (n = 873) (n; %)‡ | Dryvax (n = 289) (n; %)‡ |
|
Blood and the lymphatic system disorders
| |||
| Lymphadenopathy |
13 (1) |
72 (8) |
35 (12) |
| Lymph node pain |
1 (0.1) |
494 (57) |
199 (69) |
|
Nervous system disorders
| |||
| Headache |
280 (27) |
433 (50) |
150 (52) |
|
Respiratory, thoracic and mediastinal disorders
| |||
| Dyspnea |
0 (0) |
39 (4) |
16 (6) |
|
Gastrointestinal disorders
| |||
| Nausea |
105 (10) |
170 (19) |
65 (22) |
| Diarrhea |
8 (1) |
144 (16) |
34 (12) |
| Constipation |
0 (0) |
49 (6) |
9 (3) |
| Vomiting |
1 (0.1) |
42 (5) |
10 (3) |
|
Skin and subcutaneous tissue disorders
| |||
| Erythema |
1 (0.1) |
190 (22) |
69 (24) |
| Rash |
3 (0.3) |
94 (11) |
30 (10) |
|
Musculoskeletal, connective tissue and bone disorders
| |||
| Myalgia |
103 (10) |
404 (46) |
147 (51) |
|
General disorders and administration-site conditions
| |||
| Injection-site erythema |
827 (81) |
649 (74) |
229 (79) |
| Injection-site pain |
887 (87) |
582 (67) |
208 (72) |
| Injection-site pruritus |
211 (21) |
804 (92) |
277 (96) |
| Injection-site swelling |
692 (68) |
422 (48) |
165 (57) |
| Fatigue |
316 (31) |
423 (48) |
161 (56) |
| Malaise |
5 (0.5) |
327 (37) |
122 (42) |
| Rigors |
31 (3) |
185 (21) |
66 (23) |
| Exercise tolerance decreased |
0 (0) |
98 (11) |
35 (12) |
| Feeling hot | 1 (0.1) | 276 (32) | 97 (34) |
*Summary of published and unpublished data from incompleted and reported IMVAMUNE clinical trials.
‡Prescribing information for ACAM2000, August 2007.
Modified from [91].