Table 1.
Demographic and Baseline Characteristics (Safety Analysis Set Population)
| Characteristic | Participant groupa | ||
|---|---|---|---|
| NVX-CoV2373 (n = 1487) | Placebo (n = 745) | All (N = 2232) | |
| Age, y | |||
| Mean (SD) | 13.9 (1.4) | 13.8 (1.4) | 13.8 (1.4) |
| Median (range) | 14 (12–17) | 14 (12–17) | 14 (12–17) |
| Age group, y | |||
| 12–14 | 998 (67.1) | 500 (67.1) | 1498 (67.1) |
| 15–17 | 489 (32.9) | 245 (32.9) | 734 (32.9) |
| Sex | |||
| Male | 756 (50.8) | 416 (55.8) | 1172 (52.5) |
| Female | 731 (49.2) | 329 (44.2) | 1060 (47.5) |
| Race | |||
| African American or Black | 202 (13.6) | 108 (14.5) | 310 (13.9) |
| American Indian or Alaska Native | 32 (2.2) | 14 (1.9) | 46 (2.1) |
| Asian | 43 (2.9) | 34 (4.6) | 77 (3.4) |
| Native Hawaiian or other Pacific Islander | 3 (0.2) | 2 (0.3) | 5 (0.2) |
| White | 1115 (75.0) | 545 (73.2) | 1660 (74.4) |
| Multiracial | 82 (5.5) | 37 (5.0) | 119 (5.3) |
| Not reported | 10 (0.7) | 5 (0.7) | 15 (0.7) |
| Ethnicity | |||
| Hispanic or Latino | 274 (18.4) | 138 (18.5) | 412 (18.5) |
| Not Hispanic or Latino | 1208 (81.2) | 607 (81.5) | 1815 (81.3) |
| Not reported | 2 (0.1) | 0 | 2 (0.1) |
| Unknown | 3 (0.2) | 0 | 3 (0.1) |
| BMI categoryb | |||
| Underweight (<18.0) | 40 (2.7) | 28 (3.8) | 68 (3.0) |
| Normal (18.0–24.9) | 771 (51.8) | 417 (56.0) | 1188 (53.2) |
| Overweight | (25.0–29.9) | 270 (18.2) | 107 (14.4) |
| Obesity (≥30.0) | 406 (27.3) | 193 (25.9) | 599 (26.8) |
| Previous SARS-CoV-2 infection statusc | |||
| Positive | 234 (15.7) | 125 (16.8) | 359 (16.1) |
| Negative | 1252 (84.2) | 620 (83.2) | 1872 (83.9) |
| Missing | 1 (0.1) | 0 | 1 (0.04) |
Abbreviation: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).
Unless otherwise indicated, data are expressed as No. (%) of patients. Percentages have been rounded and may not total 100. Percentages are based on the safety analysis set within each treatment and overall.
Classified (using sex- and age-specific percentiles) as underweight, less than the 5th percentile; healthy, within the 5th percentile and up to the 85th percentile; overweight, within the 85th percentile to less than the 95th percentile; and obesity, equal to or greater than the 95th percentile.
Indicates either antinucleoprotein or reverse transcriptase–polymerase chain reaction positive findings at baseline.