Table 3.
Dose-stratified vaccine efficacy against incident HPV16/18 infection (one-time detection, six-month persistence, and 12-month persistence) for women in the total vaccinated cohort naïve, which excluded women HPV DNA-positive for any of 14 high-risk types, HPV16/18 seropositive, or had greater than negative cytology at the enrollment visit, 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 HPV16/18 | ||||||
| 3 (standard regimen) | HPV | 6634 | 241 | 25750 | 0·94 (0·82 to 1·06) | 81·4% (78·7 to 83·8%) |
| Control | 6662 | 1220 | 24275 | 5·03 (4·75 to 5·32) | ||
| 2 | HPV | 273 | 7 | 1114 | 0·63 (0·27 to 1·24) | 81·2% (59·5 to 92·3%) |
| Control | 276 | 36 | 1074 | 3·35 (2·38 to 4·59) | ||
| 1 | HPV | 138 | 3 | 556 | 0·54 (0·14 to 1·47) | 87·5% (60·9 to 97·1%) |
| Control | 100 | 17 | 394 | 4·32 (2·60 to 6·77) | ||
| Incident detection of HPV16/18 that persisted ≥6 months | ||||||
| 3 | HPV | 6634 | 38 | 26046 | 0·15 (0·10 to 0·20) | 93·6% (91·2 to 95·5%) |
| Control | 6660 | 567 | 24818 | 2·28 (2·10 to 2·48) | ||
| 2 | HPV | 273 | 2 | 1121 | 0·18 (0·03 to 0·59) | 87·9% (54·0 to 98·1%) |
| Control | 276 | 16 | 1089 | 1·47 (0·87 to 2·33) | ||
| 1 | HPV | 138 | 0 | 562 | 0·00 (0·00 to 0·53) | 100% (67·4 to 100%) |
| Control | 100 | 8 | 403 | 1·99 (0·92 to 3·77) | ||
| Incident detection of HPV16/18 that persisted ≥12 months | ||||||
| 3 | HPV | 6634 | 27 | 26073 | 0·10 (0·07 to 0·15) | 92·6% (89·2 to 95·1%) |
| Control | 6656 | 351 | 25186 | 1·39 (1·25 to 1·55) | ||
| 2 | HPV | 273 | 2 | 1121 | 0·18 (0·03 to 0·59) | 83·7% (35·7 to 97·5%) |
| Control | 276 | 12 | 1093 | 1·10 (0·59 to 1·87) | ||
| 1 | HPV | 138 | 0 | 562 | 0·00 (0·00 to 0·53) | 100% (41·1 to 100%) |
| Control | 99 | 5 | 403 | 1·24 (0·45 to 2·75) | ||