Table 5. Incidence of local and systemic tolerability symptoms recorded in the subject diary in the 7-d periods after the first and second vaccinations (safety population).
| Symptoma | Vacc | Number (%) of subjects with symptom present | P valueb | ||||
|---|---|---|---|---|---|---|---|
| IC43 100 µg (n = 33) |
IC43 100 µg w/o (n = 32) |
IC43 200 µg (n = 33) |
IC43 50 µg (n = 32) |
Placebo (n = 33) |
|||
| Erythema/ redness |
1 | 2 (6.1) | 3 (9.4) | 2 (6.1) | 1 (3.2) | 0 | 0.5071 |
| 2 | 0 | 2 (6.5) | 3 (10.0) | 0 | 0 | 0.0395* | |
| Induration | 1 | 3 (9.1) | 1 (3.1) | 6 (18.2) | 1 (3.2) | 1 (3.0) | 0.1238 |
| 2 | 2 (6.1) | 0 | 4 (13.3) | 0 | 0 | 0.0137* | |
| Itching | 1 | 0 | 0 | 0 | 1 (3.2) | 1 (3.0) | 0.5066 |
| 2 | 1 (3.0) | 0 | 0 | 0 | 0 | 1.0000 | |
| Pain | 1 | 17 (51.5) | 9 (28.1) | 17 (51.5) | 15 (48.4) | 1 (3.0) | <0.0001* |
| 2 | 16 (48.5) | 4 (12.9) | 18 (60.0) | 8 (26.7) | 2 (6.3) | <0.0001* | |
| Swelling | 1 | 3 (9.1) | 3 (9.4) | 0 | 2 (6.5) | 1 (3.0) | 0.3783 |
| 2 | 1 (3.0) | 0 | 0 | 0 | 0 | 1.0000 | |
| Tender- ness |
1 | 11 (33.3) | 9 (28.1) | 13 (39.4) | 13 (41.9) | 1 (3.0) | 0.0009* |
| 2 | 11 (33.3) | 8 (25.8) | 14 (46.7) | 13 (43.3) | 1 (3.1) | 0.0003* | |
| Excessive fatigue |
1 | 8 (24.2) | 6 (18.8) | 7 (21.2) | 4 (12.9) | 2 (6.1) | 0.2649 |
| 2 | 4 (12.1) | 4 (12.9) | 5 (16.7) | 4 (13.3) | 2 (6.3) | 0.8025 | |
| Fever | 1 | 0 | 0 | 1 (3.0) | 0 | 0 | 1.0000 |
| 2 | 0 | 0 | 1 (3.3) | 1 (3.3) | 0 | 0.4214 | |
| Flu-like symptoms |
1 | 3 (9.1) | 2 (6.3) | 2 (6.1) | 2 (6.5) | 1 (3.0) | 0.9247 |
| 2 | 3 (9.1) | 4 (12.9) | 4 (13.3) | 3 (10.0) | 1 (3.1) | 0.6375 | |
| Headache | 1 | 9 (27.3) | 4 (12.5) | 6 (18.2) | 8 (25.8) | 7 (21.2) | 0.5896 |
| 2 | 9 (27.3) | 8 (25.8) | 7 (23.3) | 10 (33.3) | 3 (9.4) | 0.2053 | |
| Muscle pain |
1 | 12 (36.4) | 4 (12.5) | 11 (33.3) | 9 (29.0) | 1 (3.0) | 0.0016* |
| 2 | 11 (33.3) | 4 (12.9) | 8 (26.7) | 7 (23.3) | 0 | 0.0017* | |
| Nausea | 1 | 1 (3.0) | 3 (9.4) | 1 (3.0) | 0 | 1 (3.0) | 0.4254 |
| 2 | 2 (6.1) | 2 (6.5) | 3 (10.0) | 3 (10.0) | 1 (3.1) | 0.7759 | |
| Other symptoms |
1 | 11 (33.3) | 3 (9.4) | 6 (18.2) | 5 (16.1) | 6 (18.2) | 0.2205 |
| 2 | 9 (27.3) | 9 (29.0) | 2 (6.7) | 6 (20.0) | 5 (15.6) | 0.1384 | |
| Rash | 1 | 0 | 0 | 1 (3.0) | 0 | 1 (3.0) | 1.0000 |
| 2 | 0 | 0 | 0 | 0 | 0 | NC | |
| Vomiting | 1 | 0 | 0 | 1 (3.0) | 0 | 0 | 1.0000 |
| 2 | 0 | 0 | 2 (6.7) | 1 (3.3) | 0 | 0.0792 | |
a Local tolerability symptoms = erythema/redness, induration, itching, pain, swelling, and tenderness. Systemic tolerability symptoms = excessive fatigue, fever, flu-like symptoms, headache, muscle pain, nausea, other symptoms, rash, and vomiting. bP values were calculated according to Fisher-Freeman-Halton test. *Statistically significant difference among treatment groups. NC, not calculable; Vacc, vaccination; w/o, without adjuvant.