Table 1.
Baseline characteristics in the safety population
| GBS6 5 μg with AlPO4(n=52) | GBS6 5 μg without AlPO4(n=52) | GBS6 10 μg with AlPO4(n=52) | GBS6 10 μg without AlPO4(n=52) | GBS6 20 μg with AlPO4(n=52) | GBS6 20 μg without AlPO4(n=52) | Placebo (n=52) | Total (n=364) | |
|---|---|---|---|---|---|---|---|---|
| Sex | ||||||||
| Female | 35 (67%) | 41 (79%) | 32 (62%) | 33 (64%) | 35 (67%) | 37 (71%) | 43 (83%) | 256 (70%) |
| Male | 17 (33%) | 11 (21%) | 20 (39%) | 19 (37%) | 17 (33%) | 15 (29%) | 9 (17%) | 108 (30%) |
| Race | ||||||||
| White | 44 (85%) | 41 (79%) | 46 (89%) | 41 (79%) | 45 (87%) | 46 (89%) | 44 (85%) | 307 (84%) |
| Black or African American | 5 (10%) | 9 (17%) | 5 (10%) | 8 (15%) | 4 (8%) | 4 (8%) | 7 (14%) | 42 (12%) |
| Other | 2 (4%) | 1 (2%) | 0 | 2 (4%) | 2 (4%) | 2 (4%) | 0 | 9 (3%) |
| Asian | 1 (2%) | 0 | 1 (2%) | 1 (2%) | 1 (2%) | 0 | 1 (2%) | 5 (1%) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 1 (<1%) |
| Ethnicity | ||||||||
| Non-Hispanic or non-Latino | 50 (96%) | 47 (90%) | 50 (96%) | 49 (94%) | 47 (90%) | 51 (98%) | 47 (90%) | 341 (94%) |
| Hispanic or Latino | 2 (4%) | 4 (8%) | 2 (4%) | 2 (4%) | 5 (10%) | 1 (2%) | 5 (10%) | 21 (6%) |
| Not reported | 0 | 1 (2%) | 0 | 0 | 0 | 0 | 0 | 1 (<1%) |
| Unknown | 0 | 0 | 0 | 1 (2%) | 0 | 0 | 0 | 1 (<1%) |
| Age at vaccination, years | ||||||||
| Mean (SD) | 32·9 (8·43) | 34·7 (9·35) | 32·8 (8·31) | 31·9 (8·10) | 33·2 (8·67) | 30·5 (8·25) | 32·8 (8·74) | 32·7 (8·57) |
| Median | 31·0 | 36·5 | 31·0 | 30·0 | 32·0 | 30·0 | 32·0 | 32·0 |
| Range | 20–49 | 18–49 | 18–48 | 19–45 | 18–49 | 18–49 | 18–48 | 18–49 |
Data are n (%) unless otherwise stated. Due to rounding, percentages might not add up to 100%. Race and ethnic group were reported by participants. AlPO4=aluminium phosphate. GBS6=group B streptococcus-containing vaccine with serotypes Ia, Ib, II, III, IV, and V.