Table 1.
Subject characteristics
| Group: | E | A | B | C | D |
|---|---|---|---|---|---|
| Characteristic | Placebo N = 60 | 60 μg + Al N = 40 | 60 μg N = 40 | 90 μg + Al N = 40 | 90 μg N = 40 |
| Gender, n (%) | |||||
| Male | 22 (37) | 18 (45) | 16 (40) | 21 (53) | 17 (43) |
| Female | 38 (63) | 22 (55) | 24 (60) | 19 (48) | 23 (58) |
| Race, n (%) | |||||
| White or Caucasian | 58 (97) | 40 (100) | 39 (98) | 37 (93) | 40 (100) |
| Black or African American | 1 (2) | 0 | 0 | 3 (8) | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| American Indian/Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian/Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Other | 1 (2) | 0 | 1 (3) | 0 | 0 |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 0 | 0 | 1 (3) | 2 (5) | 3 (8) |
| Not Hispanic or Latino | 60 (100) | 40 (100) | 39 (98) | 38 (95) | 37 (93) |
| Age Group (years), n (%) | |||||
| 60 to < 75 | 51 (85) | 34 (85) | 34 (85) | 34 (85) | 34 (85) |
| ≥ 75 | 9 (15) | 6 (15) | 6 (15) | 6 (15) | 6 (15) |
| Age (years) | |||||
| n | 60 | 40 | 40 | 40 | 40 |
| Mean (SD) | 69.1 (5.5) | 69.1 (5.8) | 67.7 (5.6) | 68.0 (5.8) | 68.7 (5.7) |
| Median | 68.0 | 68.0 | 67.0 | 68.0 | 68.0 |
| Min, Max | 60, 87 | 60, 83 | 60, 85 | 60, 85 | 61, 81 |
Percentages are based on the number of subjects in the Safety Population with non-missing data within treatment group
Age is calculated as the closest integer result of (Date of Study day 0 – Date of Birth)/365.25