Table 1.
Demographic Characteristics of Study Participants (Exposed Set)
| Participants | Adjuvanta | RSVPreF3 Antigen Concentration | No. | Age in Years at First Vaccination, Mean (SD) | Sex, No. (%) | Ethnicity, No. (%) | Race, No. (%) | ||
|---|---|---|---|---|---|---|---|---|---|
| Female | Not Hispanic or Latino | White | Black/African American | Otherb | |||||
| Young adults (18─40 y) | Plain | 30 µg | 12 | 31.2 (7.0) | 8 (66.7) | 12 (100) | 10 (83.3) | 2 (16.7) | 0 (0.0) |
| 60 µg | 12 | 26.5 (4.0) | 7 (58.3) | 11 (91.7) | 10 (83.3) | 1 (8.3) | 1 (8.3) | ||
| 120 µg | 12 | 29.9 (6.1) | 7 (58.3) | 11 (91.7) | 10 (83.3) | 2 (16.7) | 0 (0.0) | ||
| Placebo | 12 | 31.6 (5.6) | 9 (75.0) | 12 (100) | 11 (91.7) | 1 (8.3) | 0 (0.0) | ||
| Older adults (60─80 y) | Plain | 30 µg | 101 | 67.3 (5.6) | 58 (57.4) | 99 (98.0) | 95 (94.1) | 5 (5.0) | 1 (1.0) |
| 60 µg | 97 | 67.8 (5.6) | 54 (55.7) | 91 (93.8) | 90 (92.8) | 7 (7.2) | 0 (0.0) | ||
| 120 µg | 100 | 67.9 (4.9) | 57 (57.0) | 94 (94.0) | 93 (93.0) | 4 (4.0) | 0 (0.0) | ||
| AS01E | 30 µg | 101 | 67.8 (5.1) | 58 (57.4) | 98 (97.0) | 88 (87.1) | 12 (11.9) | 1 (1.0) | |
| 60 µg | 101 | 67.1 (5.6) | 57 (56.4) | 98 (97.0) | 94 (93.1) | 7 (6.9) | 0 (0.0) | ||
| 120 µg | 100 | 67.6 (5.2) | 57 (57.0) | 97 (97.0) | 93 (93.0) | 5 (5.0) | 1 (1.0) | ||
| AS01B | 30 µg | 103 | 67.6 (4.9) | 59 (57.3) | 99 (96.1) | 92 (89.3) | 11 (10.7) | 0 (0.0) | |
| 60 µg | 100 | 67.5 (4.9) | 58 (58.0) | 98 (98.0) | 93 (93.0) | 7 (7.0) | 0 (0.0) | ||
| 120 µg | 101 | 67.5 (4.9) | 57 (56.4) | 97 (96.0) | 92 (91.1) | 7 (6.9) | 1 (1.0) | ||
| Plain | Placebo | 101 | 68.1 (5.7) | 58 (57.4) | 98 (97.0) | 97 (96.0) | 4 (4.0) | 0 (0.0) | |
Abbreviations: RSVPReF3, prefusion conformation of the respiratory syncytial virus F protein; SD, standard deviation.
AS01B and AS01E, adjuvanted vaccine formulations with the corresponding vaccine adjuvant systems; Plain, unadjuvanted vaccine formulations.
Includes American Indian/Alaska Native and Asian participants.