Table 1.
Baseline Characteristics of the Participants (Exposed Population)
| Characteristic | 50–59-non-AIR-RSV (N = 383) | 50–59-non-AIR-placebo (N = 192) | 50–59-AIR-RSV (N = 386) | 50–59-AIR-placebo (N = 191) | ≥60-RSV (N = 381) |
|---|---|---|---|---|---|
| Mean (SD) age, y | 54.8 (2.8) | 54.7 (2.8) | 55.3 (2.8) | 55.6 (2.8) | 69.5 (6.9) |
| Age category, n (%) | |||||
| 50–59 y | 383 (100) | 192 (100) | 386 (100) | 191 (100) | 0 (0.0) |
| 60–69 y | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 202 (53.0) |
| 70–79 y | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 130 (34.1) |
| ≥80 y | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 49 (12.9) |
| Female sex, n (%) | 221 (57.7) | 119 (62.0) | 186 (48.2) | 85 (44.5) | 188 (49.3) |
| Race, n (%) | |||||
| American Indian or Alaska Native | 1 (0.3) | 0 (0.0) | 4 (1.0) | 3 (1.6) | 1 (0.3) |
| Asian | 41 (10.7) | 22 (11.5) | 42 (10.9) | 23 (12.0) | 43 (11.3) |
| Black or African American | 14 (3.7) | 8 (4.2) | 15 (3.9) | 3 (1.6) | 11 (2.9) |
| Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (1.0) | 1 (0.3) |
| White | 320 (83.6) | 158 (82.3) | 324 (83.9) | 158 (82.7) | 324 (85.0) |
| Multiple | 4 (1.0) | 3 (1.6) | 1 (0.3) | 1 (0.5) | 0 (0.0) |
| Unknown | 3 (0.8) | 1 (0.5) | 0 (0.0) | 1 (0.5) | 1 (0.3) |
| Mean (SD) BMI, kg/m2 | 28.4 (5.9) | 28.4 (6.7) | 30.9 (6.8) | 31.3 (7.3) | 28.2 (6.0) |
| Smoking status (tobacco), n (%) | |||||
| Current smoker | 66 (17.2) | 36 (18.8) | 83 (21.5) | 49 (25.7) | 44 (11.5) |
| Former smoker | 99 (25.8) | 37 (19.3) | 133 (34.5) | 50 (26.2) | 133 (34.9) |
| Never smoker | 217 (56.7) | 119 (62.0) | 170 (44.0) | 92 (48.2) | 204 (53.5) |
| Unknown | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any pre-existing condition,a n (%) | 320 (83.6) | 160 (83.3) | 386 (100) | 191 (100) | 358 (94.0) |
| Condition of interest,b n (%) | |||||
| 1 condition of interestb | 0 (0.0) | 0 (0.0) | 267 (69.2) | 136 (71.2) | 94 (24.7) |
| ≥2 conditions of interestb | 0 (0.0) | 0 (0.0) | 119 (30.8) | 55 (28.8) | 51 (13.4) |
| Chronic pulmonary disease | 0 (0.0) | 0 (0.0) | 148 (38.3) | 79 (41.4) | 59 (15.5) |
| Chronic cardiovascular disease | 0 (0.0) | 0 (0.0) | 125 (32.4) | 58 (30.4) | 58 (15.2) |
| Diabetes mellitus | 0 (0.0) | 0 (0.0) | 188 (48.7) | 92 (48.2) | 67 (17.6) |
| Chronic liver or renal disease | 0 (0.0) | 0 (0.0) | 57 (14.8) | 23 (12.0) | 17 (4.5) |
Abbreviations: BMI, body mass index; N, number of participants in the exposed population; SD, standard deviation; n (%), number (percentage) of participants in the indicated category; y, years; 50–59-AIR-placebo, group of 50–59-year-old participants at increased risk for respiratory syncytial virus (RSV) disease who received placebo; 50–59-AIR-RSV, group of 50–59-year-old participants at increased risk for RSV disease who received RSV prefusion F protein–based vaccine (RSVPreF3 OA); 50–59-non-AIR-placebo, group of 50–59-year-old participants without increased risk for RSV disease who received placebo; 50–59-non-AIR-RSV, group of 50–59-year-old participants without increased risk for RSV disease who received RSVPreF3 OA; ≥60-RSV, group of ≥60-year-old participants who received RSVPreF3 OA.
aAny pre-existing chronic condition based on the participant's medical history.
bConditions of interest refer to the predefined conditions that are known to increase the risk for RSV disease (chronic pulmonary disease, chronic cardiovascular disease, diabetes mellitus types 1 and 2, chronic renal disease, and chronic liver disease).