Table 4.
Immunogenicity summary of RVNA titers 6 months after the final injection in participants with a baseline titer <0.5 IU/mL (modified full analysis set).
| Low-dose PVRV-NG2 (n = 79) |
Medium-dose PVRV-NG2 (n = 80) | High-dose PVRV-NG2(n = 76) | PVRV-NG (n = 39) | HDCV (n = 39) | |
|---|---|---|---|---|---|
| Month 7 (6 months [D168 ± 14 days] post Dose 5) | |||||
| Participants with available RVNA titers at Month 7a | 66 | 75 | 69 | 29 | 33 |
| Participants with RVNA titer ≥ 0.5 IU/mL | |||||
| n (%) | 47 (71.2) | 59 (78.7) | 63 (91.3) | 21 (72.4) | 25 (75.8) |
| 95% CI | 58.7, 81.7 | 67.7, 87.3 | 82.0, 96.7 | 52.8, 87.3 | 57.7, 88.9 |
| Titers | |||||
| Geometric mean | 0.894 | 1.00 | 1.53 | 0.948 | 1.06 |
| 95% CI | 0.675, 1.18 | 0.797, 1.27 | 1.24, 1.88 | 0.647, 1.39 | 0.685, 1.63 |
Modified full analysis set was defined post hoc as the subset of randomized participants who received at least one dose of the study vaccine and had a baseline RVNA titer of < 0.5 IU/mL.
aNumber of participants with available data for the relevant endpoint.
D, day; RVNA, Rabies virus neutralizing antibody.