Table 1.
Demographics and Baseline Disease Characteristics: Safety Analysis Set
| Participants, No. (%)a | |||
|---|---|---|---|
| Parameter | NVX-CoV2515 (n = 286) | NVX-CoV2373 (n = 274) | Bivalentb (n = 269) |
| Age,c y | |||
| Mean (SD) | 40.4 (12.1) | 40.1 (11.5) | 39.9 (12.4) |
| Median | 42.0 | 41.0 | 41.0 |
| Range | 18–64 | 18–64 | 18–64 |
| Sex | |||
| Male | 133 (46.5) | 131 (47.8) | 118 (43.9) |
| Female | 153 (53.5) | 143 (52.2) | 151 (56.1) |
| Race | |||
| White | 233 (81.5) | 215 (78.5) | 220 (81.8) |
| Black or African American | 0 | 2 (0.7) | 0 |
| Aboriginal Australian | 2 (0.7) | 1 (0.4) | 2 (0.7) |
| Native Hawaiian or other Pacific Islander | 1 (0.3) | 0 | 1 (0.4) |
| Asian | 37 (12.9) | 45 (16.4) | 39 (14.5) |
| Mixed origin | 5 (1.7) | 3 (1.1) | 1 (0.4) |
| Other | 8 (2.8) | 8 (2.9) | 6 (2.2) |
| Not reported | 0 | 0 | 0 |
| Ethnicity | |||
| Australian | 252 (88.1) | 236 (86.1) | 233 (86.6) |
| Aboriginal/Torres Strait Islanders | 4 (1.4) | 3 (1.1) | 2 (0.7) |
| Hispanic or Latino | 6 (2.1) | 8 (2.9) | 6 (2.2) |
| Not reported | 12 (4.2) | 15 (5.5) | 17 (6.3) |
| Unknown | 10 (3.5) | 11 (4.0) | 9 (3.3) |
| Missing | 2 (0.7) | 1 (0.4) | 2 (0.7) |
| BMI,d kg/m2 | |||
| No. | 284 | 270 | 267 |
| Mean (SD) | 28.07 (6.4) | 28.01 (5.3) | 27.40 (5.7) |
| Median | 26.9 | 27.5 | 26.3 |
| Range | 18.1–55.8 | 17.4–47.2 | 17.7–50.1 |
| BMI category, kg/m2 | |||
| Underweight, <18.0 | 0 | 3 (1.1) | 2 (0.7) |
| Normal, 18.0–24.9 | 106 (37.1) | 75 (27.4) | 104 (38.7) |
| Overweight, 25.0–29.9 | 87 (30.4) | 108 (39.4) | 90 (33.5) |
| Obese, ≥30.0 | 91 (31.8) | 84 (30.7) | 71 (26.4) |
| Missing | 2 (0.7) | 4 (1.5) | 2 (0.7) |
| Regimen of previous COVID-19 vaccine | |||
| Moderna | 0 | 2 (0.7) | 5 (1.9) |
| Pfizer-BioNTech | 213 (74.5) | 214 (78.1) | 200 (74.3) |
| Mixed | 73 (25.5) | 58 (21.2) | 64 (23.8) |
| Moderna-Moderna-Pfizer | 1 (0.3) | 1 (0.4) | 0 |
| Moderna-Pfizer-Pfizer | 2 (0.7) | 0 | 1 (0.4) |
| Moderna-Pfizer-Moderna | 0 | 0 | 0 |
| Pfizer-Pfizer-Moderna | 70 (24.5) | 56 (20.4) | 63 (23.4) |
| Pfizer-Moderna-Moderna | 0 | 1 (0.4) | 0 |
| Pfizer-Moderna-Pfizer | 0 | 0 | 0 |
| Previous COVID-19 | |||
| Yes | 18 (6.3) | 19 (6.9) | 17 (6.3) |
| No | 268 (93.7) | 255 (93.1) | 252 (93.7) |
| Qualitative anti-N | |||
| Positive | 145 (50.7) | 141 (51.5) | 134 (49.8) |
| Negative | 141 (49.3) | 133 (48.5) | 135 (50.2) |
| rRT-PCR | |||
| Positive | 11 (3.8) | 12 (4.4) | 14 (5.2) |
| Negative | 275 (96.2) | 262 (95.6) | 255 (94.8) |
| Anti-N/rRT-PCRe | |||
| Positive | 149 (52.1) | 145 (52.9) | 137 (50.9) |
| Negative | 137 (47.9) | 129 (47.1) | 132 (49.1) |
| Time between last COVID-19 vaccine and booster dose of study vaccine, d | |||
| Mean (SD) | 178.2 (38.5) | 182.4 (36.4) | 178.7 (36.6) |
| Median | 177.0 | 182.0 | 180.0 |
| Range | 84–440 | 91–329 | 77–313 |
| Interval between last COVID-19 vaccine and booster dose of study vaccine, d | |||
| <90 | 1 (0.3) | 0 | 1 (0.4) |
| 90–120 | 15 (5.2) | 15 (5.5) | 18 (6.7) |
| >120–150 | 43 (15.0) | 35 (12.8) | 36 (13.4) |
| >150–180 | 98 (34.3) | 81 (29.6) | 81 (30.1) |
| >180–210 | 87 (30.4) | 97 (35.4) | 94 (34.9) |
| >210–240 | 26 (9.1) | 32 (11.7) | 25 (9.3) |
| >240–270 | 10 (3.5) | 9 (3.3) | 11 (4.1) |
| >270–300 | 4 (1.4) | 2 (0.7) | 1 (0.4) |
| >300–330 | 1 (0.3) | 3 (1.1) | 2 (0.7) |
| >330–360 | 0 | 0 | 0 |
| >360 | 1 (0.3) | 0 | 0 |
Each participant received 5 µg of SARS-CoV-2 recombinant spike protein nanoparticle vaccine with 50 µg of Matrix-M adjuvant. Participants in the safety analysis set are counted according to the treatment received to accommodate for treatment errors. The sample number for continuous parameters represents the number of participants with nonmissing values.
Abbreviations: anti-N, antinucleocapsid; BMI, body mass index; rRT-PCR, real-time reverse transcriptase polymerase chain reaction.
aData are presented as No. (%) unless noted otherwise.
bNVX CoV2373 + NVX-CoV2515.
cAge was calculated at the time of informed consent.
dBMI was calculated as weight (kilograms) divided by height squared (meters). Percentages were based on the safety analysis set within each treatment and overall.
eParticipants with either anti-N or rRT-PCR are reported.