Table 1. Demographics and Baseline Characteristics of the Participants Included in the Safety Analysis Set.
NVX-CoV2373 was 5 μg recombinant spike protein with 50 μg Matrix-M1. BMI was calculated as weight (kg) divided by squared height (m). SARS-CoV-2 serostatus was determined by IgG antibody to recombinant spike protein (anti-spike IgG). Baseline serostatus was defined by antibody level detected by anti-spike IgG ELISA using GMT at Day 0. Percentages were based on safety analysis set within each treatment and overall.
Note: Values are represented as n (%), unless otherwise stated.
| Vaccine Group | NVX-CoV2373 | Placebo | Overall |
|---|---|---|---|
| N | 2199 | 2188 | 4387 |
| Age (years) | |||
| n | 2196 | 2186 | 4382 |
| Mean (SD) | 31.9 (12.91) | 32.2 (13.08) | 32.0 (13.00) |
| Median | 28.0 | 28.0 | 28.0 |
| Age Group | |||
| ≥18 to 64 years | 2104 (95.7) | 2094 (95.7) | 4198 (95.7) |
| ≥65 to 84 years | 92 (4.2) | 92 (4.2) | 184 (4.2) |
| Sex | |||
| Male | 1252 (56.9) | 1266 (57.9) | 2518 (57.4) |
| Female | 947 (43.1) | 922 (42.1) | 1869 (42.6) |
| Race | |||
| Black | 2098 (95.4) | 2082 (95.2) | 4180 (95.3) |
| White | 86 (3.9) | 66 (3.0) | 152 (3.5) |
| Other | 40 (1.8) | 49 (2.2) | 89 (2.0) |
| Baseline BMI (kg/m2) | |||
| n | 2195 | 2186 | 4381 |
| Mean (SD) | 25.06 (6.004) | 25.02 (5.930) | 25.04 (5.967) |
| ≥30 to 40 | 451 (20.5) | 440 (20.1) | 891 (20.3) |
| Underlying Chronic Conditions | |||
| Hypertension | 125 (5.7) | 119 (5.4) | 244 (5.6) |
| Type 2 diabetes | 31 (1.4) | 39 (1.8) | 70 (1.6) |
| Day 0 SARS-CoV-2 NAAT Positive | 63 (2.9) | 63 (2.9) | 126 (2.9) |
| Day 0 SARS-CoV-2 Anti-Spike IgG Seropositive | 651 (29.6) | 673 (30.8) | 1324 (30.2) |
Abbreviations: BMI = body mass index; ELISA = enzyme-linked immunosorbent assay; GMT = geometric mean titer; IgG = immunoglobulin G; NAAT = nucleic acid amplification test; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SD = standard deviation.