Table 1 Summary of demographics of the participants who received study intervention (safety set).
MVC-COV1901 (N = 341) | Placebo (N = 58) | All subjects (N = 399) | P-value | |
---|---|---|---|---|
Age | 0.6045 (Mann–Whitney U test) | |||
Mean (SD) | 14.4 (1.65) | 14.2 (1.48) | 14.3 (1.62) | |
Min–Max | 12.0–17.0 | 12.0–17.0 | 12.0–17.0 | |
Gender, n (%) | 0.0429 (Chi-square test) | |||
Male | 190 (55.7) | 24 (41.4) | 214 (53.6) | |
Female | 151 (44.3) | 34 (58.6) | 185 (46.4) | |
Race, n (%) | ||||
Asian | 341 (100.0) | 58 (100.0) | 399 (100.0) | |
Non-Asian | 0 | 0 | 0 | |
BMI (kg/m2), | 0.3035 (Mann–Whitney U test) | |||
Mean (SD) | 21.2 (4.2) | 21.9 (4.5) | 21.3 (4.2) | |
Min–Max | 15.2–42.3 | 15.3–32.3 | 15.2–42.3 | |
BMI group, n (%) | 0.0667 (Fisher’s exact test) | |||
<30 kg/m2 | 330 (96.8) | 53 (91.4) | 383 (96.0) | |
≥30 kg/m2 | 11 (3.2) | 5 (8.6) | 16 (4.0) | |
HIV antibody, n (%) | 0 | 0 | 0 | |
Pre-vaccination neutralizing antibody against wild type SARS-CoV-2 (≥8), n (%) | 4 (1.2) | 1 (1.7) | 5 (1.3) | 0.5460 (Fisher’s exact test) |
Pre-vaccination anti-SARS-CoV-2 IgG (≥100), n (%) | 10 (2.9) | 2 (3.4) | 12 (3.0) | 0.6888 (Fisher’s exact test) |
Comorbidity, n (%) | ||||
Any | 7 (2.1) | 1 (1.7) | 8 (2.0) | |
Cardiovascular disease | 0 | 0 | 0 | |
Cerebrovascular disease | 0 | 0 | 0 | |
COPD | 0 | 0 | 0 | |
Liver cirrhosis | 0 | 0 | 0 | |
Malignancy | 1 (0.3) | 0 | 1 (0.3) | |
HbAlc higher than 5.7% DCCT | 6 (1.8) | 1 (1.7) | 7 (1.8) |