Table 5.
Timing of 2nd doses | Arm | Women, no. | Events, no. | Person years | Rate per 1000 PY (95%CI) | Vaccine Efficacy |
---|---|---|---|---|---|---|
Incident one-time detection of HPV16/18 | ||||||
1 month | HPV | 300 | 12 | 1334 | 0·90 (0·49 to 1·53) | 75·3% (54·2 to 87·5%) |
Control | 283 | 44 | 1208 | 3·64 (2·68 to 4·85) | ||
6 months | HPV | 97 | 3 | 441 | 0·68 (0·17 to 1·85) | 82·6% (42·3 to 96·1%) |
Control | 72 | 12 | 307 | 3·91 (2·12 to 6·65) | ||
Incident one-time detection of HPV31/33/45 | ||||||
1 month | HPV | 303 | 36 | 1304 | 2·76 (1·96 to 3·78) | 10·2% (−42·0 to 43·3%) |
Control | 286 | 38 | 1236 | 3·07 (2·21 to 4·18) | ||
6 months | HPV | 98 | 8 | 431 | 1·86 (0·86 to 3·53) | 68·1% (27·0 to 87·0%)* |
Control | 72 | 17 | 292 | 5·82 (3·50 to 9·13) |
The observed difference in the cross-protective VEs was significantly greater among women who received their second dose at six months compared to one month (p= 0·029).