Table 1.
Demographic Characteristics of Participants in the Safety Populations of the Month and Day Regimens
| Characteristic | Month Regimen Vaccine Group | Day Regimen Vaccine Group | ||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (na = 61) |
100 µg C. diff (na = 183) |
200 µg C. diff (na = 183) |
Total (Na = 427) |
Placebo (na = 61) |
100 µg C. diff (na = 182) |
200 µg C. diff (na = 184) |
Total (Na = 427) |
|
| Sex, nb (%) | ||||||||
| Female | 37 (60.7) | 93 (50.8) | 97 (53.0) | 227 (53.2) | 35 (57.4) | 93 (51.1) | 106 (57.6) | 234 (54.8) |
| Male | 24 (39.3) | 90 (49.2) | 86 (47.0) | 200 (46.8) | 26 (42.6) | 89 (48.9) | 78 (42.4) | 193 (45.2) |
| Race, nb (%) | ||||||||
| White | 56 (91.8) | 151 (82.5) | 157 (85.8) | 364 (85.2) | 59 (96.7) | 172 (94.5) | 168 (91.3) | 399 (93.4) |
| Black | 3 (4.9) | 16 (8.7) | 13 (7.1) | 32 (7.5) | 2 (3.3) | 6 (3.3) | 16 (8.7) | 24 (5.6) |
| Asian | 1 (1.6) | 13 (7.1) | 10 (5.5) | 24 (5.6) | 0 (0.0) | 2 (1.1) | 0 (0.0) | 2 (0.5) |
| Other | 1 (1.6) | 3 (1.6) | 3 (1.6) | 7 (1.6) | 0 (0.0) | 2 (1.1) | 0 (0.0) | 2 (0.5) |
| Ethnicity, nb (%) | ||||||||
| Non-Hispanic/non-Latino | 57 (93.4) | 168 (91.8) | 172 (94.0) | 397 (93.0) | 48 (78.7) | 127 (69.8) | 143 (77.7) | 318 (74.5) |
| Hispanic/Latino | 4 (6.6) | 15 (8.2) | 11 (6.0) | 30 (7.0) | 13 (21.3) | 55 (30.2) | 41 (22.3) | 109 (25.5) |
| Age at randomization, y | ||||||||
| Mean (standard deviation) | 70.4 (4.65) | 71.5 (4.96) | 71.3 (4.70) | 71.3 (4.81) | 71.9 (5.27) | 71.4 (4.89) | 71.2 (5.04) | 71.4 (5.01) |
| Median | 69.0 | 71.0 | 71.0 | 71.0 | 71.0 | 71.0 | 70.0 | 70.0 |
| Min, max | 65, 81 | 65, 85 | 65, 84 | 65, 85 | 65, 85 | 65, 84 | 65, 85 | 65, 85 |
| Baseline Clostridium difficile serostatus,c nb (%) | ||||||||
| Seronegative | ||||||||
| Toxin A−/toxin B− | 40 (65.6) | 135 (73.8) | 123 (67.2) | 298 (69.8) | 44 (72.1) | 141 (77.5) | 137 (74.5) | 322 (75.4) |
| Seropositive | ||||||||
| Toxin A+/toxin B− | 3 (4.9) | 16 (8.7) | 18 (9.8) | 37 (8.7) | 4 (6.6) | 6 (3.3) | 11 (6.0) | 21 (4.9) |
| Toxin A−/toxin B+ | 17 (27.9) | 28 (15.3) | 36 (19.7) | 81 (19.0) | 11 (18.0) | 31 (17.0) | 28 (15.2) | 70 (16.4) |
| Toxin A+/toxin B+ | 1 (1.6) | 4 (2.2) | 6 (3.3) | 11 (2.6) | 2 (3.3) | 4 (2.2) | 7 (3.8) | 13 (3.0) |
| Toxin A and/or toxin B not evaluated | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 1 (0.2) |
| Toxin A not evaluated | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 1 (0.2) |
| Toxin B not evaluated | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 1 (0.2) |
| Toxin A and B not evaluated | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5) | 1 (0.2) |
Includes all participants who received at least 1 dose of an investigational product.
Abbreviation: C diff, Clostridium difficile vaccine.
an or N = total number of participants in the specified group.
bn = number of participants with the specified characteristic.
cBaseline serostatus (before dose 1 on day 1) defined based on lower limit of quantitation (LLOQ) value for toxin A– or toxin B–specific neutralizing antibody level, with “+” indicating neutralizing antibody level ≥LLOQ and “–“ indicating neutralizing antibody level <LLOQ.