Table 4.
Number and Proportions of Subjects with Positive S. aureus Nasal (a), Oral (b), and Nasal/Oral (c) Cultures by Visit Number and Treatment Arm Among S. aureus Nasal, Oral, and Nasal/Oral Colonization Negative Subjects at Screening
| Study Visit | No. of Incident S. aureus Colonization within Interval (No. at risk)a | Interval Proportion (95% CI)b | Cumulative No. of S. aureus Colonization up to the Study Visit | Cumulative Proportion (95% CI)b | No. of Incident S. aureus Colonization within Interval (No. at risk)a | Interval Proportion (95% CI)b | Cumulative No. of S. aureus Colonization up to the Study Visit | Cumulative Proportion (95% CI)b |
|---|---|---|---|---|---|---|---|---|
| Subjects with Positive S. aureus Nasal Cultures | ||||||||
| NDV-3A Vaccine (N=125) c | Placebo (N=127) c | |||||||
| Visit 3 | 19 (125) | 0.15 (0.09–0.23) |
19 | 0.15 (0.09–0.23) |
17 (125) | 0.14 (0.08–0.21) |
17 | 0.14 (0.08–0.21) |
| Visit 4 | 6 (99) | 0.06 (0.02–0.13) |
25 | 0.20 (0.13–0.28) |
9 (106) | 0.08 (0.04–0.16) |
26 | 0.20 (0.14–0.29) |
| Visit 5 | 7 (93) | 0.08 (0.03–0.15) |
32 | 0.26 (0.18–0.34) |
11 (92) | 0.12 (0.06–0.20) |
37 | 0.29 (0.21–0.38) |
| Visit 6 | 4 (78) | 0.05 (0.01–0.13) |
36 | 0.29 (0.21–0.38) |
4 (77) | 0.05 (0.01–0.13) |
41 | 0.32 (0.24–0.41) |
| Subjects with Positive S. aureus Oral Cultures | ||||||||
| NDV-3A Vaccine (N=96) c | Placebo (N=97) c | |||||||
| Visit 3 | 15 (96) | 0.16 (0.09–0.25) |
15 | 0.16 (0.09–0.25) |
15 (95) | 0.16 (0.09–0.25) |
15 | 0.15 (0.09–0.24) |
| Visit 4 | 11 (77) | 0.14 (0.07–0.24) |
26 | 0.27 (0.19–0.37) |
7 (81) | 0.09 (0.04–0.17) |
22 | 0.23 (0.15–0.32) |
| Visit 5 | 2 (64) | 0.03 (0.004–0.11) |
28 | 0.29 (0.20–0.39) |
7 (72) | 0.10 (0.04–0.19) |
29 | 0.30 (0.21–0.40) |
| Visit 6 | 3 (60) | 0.05 (0.01–0.14) |
31 | 0.32 (0.23–0.43) |
4 (65) | 0.06 (0.02–0.15) |
33 | 0.34 (0.25–0.44) |
| Subjects with Positive S. aureus Nasal/Oral Cultures | ||||||||
| NDV-3A Vaccine (N=76) c | Placebo (N=76) c | |||||||
| Visit 3 | 18 (76) | 0.24 (0.15–0.35) |
18 | 0.24 (0.15–0.35) |
15 (76) | 0.20 (0.12–0.31) |
15 | 0.20 (0.12–0.31) |
| Visit 4 | 9 (55) | 0.16 (0.08–0.29) |
27 | 0.36 (0.25–0.47) |
8 (60) | 0.13 (0.06–0.25) |
23 | 0.30 (0.20–0.42) |
| Visit 5 | 3 (45) | 0.07 (0.01–0.18) |
30 | 0.39 (0.28–0.51) |
9 (51) | 0.18 (0.08–0.31) |
32 | 0.42 (0.31–0.54) |
| Visit 6 | 3 (40) | 0.08 (0.02–0.20) |
33 | 0.43 (0.32–0.55) |
3 (42) | 0.07 (0.02–0.20) |
35 | 0.46 (0.35–0.58) |
a
Number still at risk (S. aureus negative) at the beginning of the interval (subjects who do not have data available at a given visit are not included in the number at risk for that visit)
b
Clopper-Pearson 95% confidence interval
c
Number of subjects in the full analysis population with negative S. aureus nasal colonization at screening