Table 3.
Worst grade | After dose 1 | After dose 2 | |||||||
---|---|---|---|---|---|---|---|---|---|
Vaccine group (N=30) | Placebo group (N=10) | Vaccine group (N=29) | Placebo group (N=10) | ||||||
n (%**) | 95% CI | n (%**) | 95% CI | n (%**) | 95% CI | n (%**) | 95% CI | ||
Any laboratory abnormalities* | 4 (13.3) | 3.8–30.7 | 1 (10.0) | 0.3–44.5 | 1 (3.4) | 0.1–17.8 | 1 (10.0) | 0.3–44.5 | |
Blood chemistry | |||||||||
Blood bilirubin increased | mild | 1 (3.3) | 0.1–17.2 | 0 (0.0) | 0.0–30.8 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Haematological blood tests | |||||||||
Monocyte count increased | mild | 2 (6.6) | 0.8–22.1 | 0 (0.0) | 0.0–30.8 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Eosinophil count increased | mild | 1 (3.3) | 0.1–17.2 | 0 (0.0) | 0.0–30.8 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Lymphocyte count increased | mild | 1 (3.3) | 0.1–17.2 | 2 (20.0) | 2.5–55.6 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Neutrophil count decreased | mild | 2 (6.6) | 0.8–22.1 | 0 (0.0) | 0.0–30.8 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Erythrocyte sedimentation rate | mild | 2 (6.6) | 0.8–22.1 | 0 (0.0) | 0.0–30.8 | 0 (0.0) | 0.0–11.9 | 0 (0.0) | 0.0–30.8 |
Urinalysis | |||||||||
Traces of protein | mild | 0 (0.0) | 0.0–30.8 | 1 (3.4) | 0.1–17.8 | 1 (10.0) | 0.3–44.5 | ||
Any serious adverse event | 0 | 0 | 0 | 0 |
CI = confidence interval (%)
A subject with more than one finding in a specific category was counted only once.
Percentages based on total number of subjects in each treatment group.