Table 1. Demographic characteristics of the participants at enrollment (Safety Analysis Set).
| AGEU Group |
A | B | C | D | E | TOTAL 1,283 |
|---|---|---|---|---|---|---|
| Study Treatments Dose 1 / Dose 2 | Placebo / Placebo | 5 μg + M1 / 5 μg + M1 | 5 μg + M1 / Placebo | 25 μg + M1 / 25 μg + M1 | 25 μg + M1 / Placebo | |
| Characteristic N | 255 | 258 | 256 | 259 | 255 | |
| Sex–no. (%) | ||||||
| Male | 132 (51.8) | 119 (46.1) | 136 (53.1) | 122 (47.1) | 121 (47.5) | 630 (49.1) |
| Female | 123 (48.2) | 139 (53.9) | 120 (46.9) | 137 (52.9) | 134 (52.5) | 653 (50.9) |
| Age–years | ||||||
| All– 18–84 mean (SD) | 51.8 (17.17) | 51.3 (17.47) | 52.7 (16.82) | 52.5 (16.60) | 53.9 (16.14) | 52.4 (16.84) |
| 18–59 no. (% of total) | 139 (54.5) | 140 (54.3) | 139 (54.3) | 144 (55.6) | 138 (54.1) | 700 (54.6) |
| mean (SD) | 38.9 (12.40) | 38.2 (12.54) | 40.2 (12.17) | 40.8 (12.60) | 42.3 (12.45) | 40.1 (12.48) |
| 60–84 no. (% of total) | 116 (45.5) | 118 (45.7) | 117 (45.7) | 115 (44.4) | 117 (45.9) | 583 (45.4) |
| mean (SD) | 67.1 (5.31) | 66.9 (5.71) | 67.5 (5.94) | 67.2 (5.55) | 67.7 (5.90) | 67.3 (5.68) |
| 75–84 no. (% of total) | 13 (5.1) | 14 (5.4) | 18 (7.0) | 17 (6.6) | 21 (8.2) | 83 (6.5) |
| mean (SD) | 77.1 (2.53) | 77.5 (2.38) | 78.3 (2.33) | 76.8 (1.56) | 77.8 (3.06) | 77.5 (2.46) |
| Race or ethnic group–no. (%) | ||||||
| White | 228 (89.4) | 225 (87.2) | 216 (84.4) | 222 (85.7) | 223 (87.5) | 1,114 (86.8) |
| Black or African American | 6 (2.4) | 7 (2.7) | 7 (2.7) | 11 (4.2) | 6 (2.4) | 37 (2.9) |
| Asian | 16 (6.3) | 18 (7.0) | 25 (9.8) | 20 (7.7) | 19 (7.5) | 98 (7.6) |
| American Indian or Alaska Native | 2 (0.8) | 2 (0.8) | 2 (0.8) | 1 (0.4) | 1 (0.4) | 8 (0.6) |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 0 | 1 (0.4) | 1 (<0.1) |
| Multiracial | 3 (1.2) | 3 (1.2) | 3 (1.2) | 3 (1.2) | 3 (1.2) | 15 (1.2) |
| Not reported/missing | 0 | 3 (1.2) | 3 (1.2) | 2 (0.8) | 2 (0.8) | 10 (0.8) |
| Hispanic or Latino | 15 (5.9) | 6 (2.3) | 12 (4.7) | 7 (2.7) | 11 (4.3) | 51 (4.0) |
| Body mass index*† | 26.76 (4.244) | 27.10 (4.121) | 26.35 (4.232) | 27.26 (3.930) | 26.78 (4.067) | 26.85 (4.126) |
| Baseline SARS-CoV-2 Serostatus–no. (%) | ||||||
| Seropositive‡ | 6 (2.4) | 5 (1.9) | 6 (2.3) | 7 (2.7) | 7 (2.7) | 31 (2.4) |
| Country of participants–no. (%) | ||||||
| Australia | 130 (51.0) | 134 (51.9) | 132 (51.6) | 133 (51.4) | 130 (51.0) | 659 (51.4) |
| United States | 125 (49.0) | 124 (48.1) | 124 (48.4) | 126 (48.6) | 125 (49.0) | 624 (48.6) |
*Means ± SD.
†The body mass index is the weight in kilograms divided by the square of the height in meters. This calculation was based on the weight and height measured at the time of screening.
‡Seropositive—Day 0 seropositivity to serum IgG antibody to SARS-CoV-2 proteins.
IgG, immunoglobulin G; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SD, standard deviation.