Table 1.
Participant demographic characteristics (full analysis set) per treatment group for participants in the one-dose cohort
| Low-dose plus AF03 group (n=34) | Low-dose plus AS03 group (n=34) | High-dose plus AF03 group (n=34) | High-dose plus AS03 group (n=34) | Placebo group (n=34) | ||
|---|---|---|---|---|---|---|
| Aged 18–49 years | ||||||
| Sex | ||||||
| Female | 14/24 (58%) | 9/24 (38%) | 13/24 (54%) | 14/24 (58%) | 12/24 (50%) | |
| Male | 10/24 (42%) | 15/24 (62%) | 11/24 (46%) | 10/24 (42%) | 12/24 (50%) | |
| Age, years | 36·0 (10·0) | 35·4 (8·66) | 32·0 (9·69) | 29·7 (8·88) | 31·1 (8·45) | |
| Race or ethnicity | ||||||
| White | 20/24 (83%) | 21/24 (88%) | 22/24 (92%) | 16/24 (67%) | 20/24 (83%) | |
| Asian | 1/24 (4%) | 2/24 (8%) | 1/24 (4%) | 4/24 (17%) | 1/24 (4%) | |
| American Indian or Alaska Native | 0 | 0 | 0 | 1/24 (4%) | 1/24 (4%) | |
| Black or African American | 1/24 (4%) | 0 | 0 | 1/24 (4%) | 0 | |
| Multiple | 0/24 | 1/24 (4%) | 1/24 (4%) | 0 | 1/24 (4%) | |
| Not reported or unknown | 2/24 (8%) | 0/24 | 0/24 | 2/24 (8%) | 1/24 (4%) | |
| Hispanic or Latino | 6/24 (25%) | 2/24 (8%)* | 3/24 (13%) | 3/24 (13%) | 7/24 (29%) | |
| Aged 50 years or older | ||||||
| Sex | ||||||
| Female | 8/10 (80%) | 6/10 (60%) | 4/10 (40%) | 7/10 (70%) | 6/10 (60%) | |
| Male | 2/10 (20%) | 4/10 (40%) | 6/10 (60%) | 3/10 (30%) | 4/10 (40%) | |
| Age, years | 59·3 (7·07) | 57·3 (5·70) | 58·5 (9·29) | 61·3 (10·1) | 60·1 (7·74) | |
| Race or ethnicity | ||||||
| White | 9/10 (90%) | 7/10 (70%) | 8/10 (80%) | 9/10 (90%) | 10/10 (100%) | |
| Asian | 1/10 (10%) | 1/10 (10%) | 0 | 1/10 (10%) | 0 | |
| Black or African American | 0 | 1/10 (10%) | 0 | 0 | 0 | |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | |
| Native Hawaiian or Other Pacific Islander | 0 | 1/10 (10%) | 0 | 0 | 0 | |
| Multiple | 0 | 0 | 1/10 (10%) | 0 | 0 | |
| Not reported or unknown | 0 | 0 | 1/10 (10%) | 0 | 0 | |
Data are n/N (%) or mean (SD).
Hispanic or Latino ethnicity was not reported for one participant in the high-dose plus AF03 group, in the 18–49 years stratum.