TABLE 1.
Infant demographics and findings at screeninga
| Parameter | Result for infants vaccinated with: |
Pb | |
|---|---|---|---|
| BCG (n = 12) | VPM1002 (n = 36) | ||
| Mean age in days (SD) | 2.6 (1.31) | 2.1 (1.27) | 0.2482 |
| No. (%) of male subjects | 6 (50.0) | 21 (58.3) | 0.7406 |
| Ethnic origin, no. (%) of subjects | 0.4997 | ||
| Caucasian | 1 (8.3) | 2 (5.6) | |
| Mixed | 10 (83.3) | 28 (72.2) | |
| Black | 1 (8.3) | 6 (22.2) | |
| Mean birth wt, kg (SD) | 3.37 (0.271) | 3.40 (0.270) | 0.7252 |
| Mean wt at screening, kg (SD) | 3.31 (0.353) | 3.35 (0.328) | 0.6833 |
| Mean Apgar score (SD) | 9.8 (0.39) | 9.6 (0.49) | 0.1640 |
| Mean recumbent length, cm (SD) | 49.0 (1.91) | 50.4 (1.98) | 0.0392* |
| Mean mid-upper-arm circumference, cm (SD) | 10.8 (0.68) | 10.9 (0.70) | 0.6504 |
| Mean body temp, °C (SD) | 36.5 (0.24) | 36.5 (0.40) | 0.8041 |
| Mean heart rate, bpm (SD) | 133 (12.9) | 129 (10.1) | 0.3811 |
a
n, total number of subjects in each treatment group; SD, standard deviation; bpm, beats per minute.
b
P values were obtained using ANOVA with treatment as the main effect (continuous data) or the Fisher exact test (categorical data). *, P < 0.05.