Table 3.
Vaccine Efficacy
| CMV gB/MF59 | Placebo | ||||||
|---|---|---|---|---|---|---|---|
| n CMV infection (%) | N | n CMV infection (%) | N | Vaccine Efficacy (%) [1] | 95% CI for Vaccine Efficacy [2] | P-value [3] | |
| CMV Infection after 3 Doses | |||||||
| Per Protocol after 3 Doses | 8 (6.5%) | 124 | 14(11.2%) | 125 | 42.9 | −36.2, 76.0 | 0.200 |
| Intention to Treat after 3 Doses | 13 (7.7%) | 168 | 18 (9.9%) | 181 | 23.2 | −56.7, 62.4 | 0.466 |
| CMV Infection after 2 Doses | |||||||
| Per Protocol after 2 Doses | 13 (7.9%) | 164 | 24 (14.0%) | 172 | 44.5 | −8.9, 71.8 | 0.082 |
| Intention to Treat after 2 Doses | 20 (10.8%) | 186 | 25 (12.6%) | 199 | 15.0 | −53.1, 52.8 | 0.589 |
| CMV Infection after 1 Dose | |||||||
| Per Protocol after 1 Dose | 18 (9.5%) | 189 | 26(13.5%) | 192 | 30.7 | −26.4, 62.0 | 0.229 |
| Intention to Treat after 1 Dose | 21 (10.8%) | 195 | 27 (13.2%) | 205 | 18.5 | −44.1, 53.9 | 0.480 |
Note: N = Number of subjects in specific treatment group. n = Number of subjects with CMV infection.
Vaccine efficacy is obtained from Cox regression.
95% CI = 95% confidence interval obtained from Cox regression.
P-value = result of comparison of Kaplan-Meier survival curves between groups by Log-rank test.