Table 4.
Dose-stratified vaccine efficacy against incident HPV31/33/45 infection (one-time detection, six-month persistence, and 12-month persistence) for women in the modified total vaccinated cohort in CVT and PATRICIA combined.
| Doses, no. | Arm | Women, no. | Events, no. | Person years | Rate per 100 PY (95%CI) | Vaccine Efficacy |
|---|---|---|---|---|---|---|
| Incident one-time detection of HPV31/33/45 | ||||||
| 3 (standard regimen) | HPV | 11156 | 710 | 42990 | 1·65 (1·53 to 1·78) | 59·7% (56·0 to 63·0%) |
| Control | 11272 | 1713 | 41837 | 4·09 (3·90 to 4·29) | ||
| 2 | HPV | 615 | 55 | 2490 | 2·21 (1·68 to 2·85) | 37·7% (12·4 to 55·9%) |
| Control | 577 | 81 | 2285 | 3·54 (2·83 to 4·38) | ||
| 1 | HPV | 293 | 26 | 1185 | 2·19 (1·46 to 3·17) | 36·6% (−5·4 to 62·2%) |
| Control | 253 | 35 | 1012 | 3·46 (2·45 to 4·75) | ||
| Incident detection of HPV31/33/45 that persisted ≥6 months | ||||||
| 3 | HPV | 11150 | 266 | 43507 | 0·61 (0·54 to 0·69) | 60·1% (54·0 to 65·4%) |
| Control | 11269 | 659 | 42997 | 1·53 (1·42 to 1·65) | ||
| 2 | HPV | 615 | 18 | 2549 | 0·71 (0·43 to 1·09) | 30·7% (−27·9 to 63·0%) |
| Control | 577 | 24 | 2355 | 1·02 (0·67 to 1·49) | ||
| 1 | HPV | 293 | 9 | 1222 | 0·74 (0·36 to 1·35) | 48·8% (−16·9 to 78·5%) |
| Control | 253 | 15 | 1043 | 1·44 (0·84 to 2·32) | ||
| Incident detection of HPV31/33/45 that persisted ≥12 months | ||||||
| 3 | HPV | 11150 | 175 | 43682 | 0·40 (0·34 to 0·46) | 54·9% (46·2 to 62·3%) |
| Control | 11266 | 386 | 43447 | 0·89 (0·80 to 0·98) | ||
| 2 | HPV | 615 | 11 | 2569 | 0·43 (0·23 to 0·74) | 7·6% (−117·8 to 60·8%) |
| Control | 577 | 11 | 2373 | 0·46 (0·24 to 0·81) | ||
| 1 | HPV | 293 | 5 | 1230 | 0·41 (0·15 to 0·90) | 46·1% (−66·8 to 84·0%) |
| Control | 253 | 8 | 1061 | 0·75 (0·35 to 1·43) | ||