Table 1.
Efficacy of Quadrivalent Vaccine against the Development of External Genital Lesions in the Intention-to-Treat Population.*
| Variable | Quadrivalent HPV Vaccine | Placebo | Observed Efficacy (95% CI) % |
||||
|---|---|---|---|---|---|---|---|
| Cases of EGL no. |
Person-Yr at Risk | Rate no./100 person-yr at risk |
Cases of EGL no. |
Person-Yr at Risk | Rate no./100 person-yr at risk |
||
| HPV type | |||||||
| Any type | 36 | 4612.6 | 0.80 | 89 | 4538.6 | 2.00 | 60.2 (40.8 to 73.8) |
| Type 6, 11, 16, or 18† | 27 | 4625.7 | 0.58 | 77 | 4556.5 | 1.69 | 65.5 (45.8 to 78.6) |
| Type 6 | 21 | 4635.8 | 0.45 | 51 | 4576.0 | 1.11 | 59.4 (31.2 to 76.8) |
| Type 11 | 6 | 4663.7 | 0.13 | 25 | 4606.6 | 0.54 | 76.3 (40.8 to 92.0) |
| Type 16 | 3 | 4663.1 | 0.06 | 10 | 4621.9 | 0.22 | 70.3 (−15.5 to 94.7) |
| Type 18 | 2 | 4670.0 | 0.04 | 3 | 4627.9 | 0.06 | 33.9 (−476.7 to 94.5) |
| Sexual orientation‡ | |||||||
| Heterosexual males | 21 | 4153.9 | 0.51 | 57 | 4087.5 | 1.39 | 63.7 (39.3 to 79.1) |
| Males who had sex with male partners | 6 | 471.8 | 1.27 | 20 | 469.0 | 4.26 | 70.2 (23.0 to 90.2) |
| Lesion type | |||||||
| Condyloma acuminatum§ | 24 | 4635.4 | 0.52 | 72 | 4558.8 | 1.58 | 67.2 (47.3 to 80.3) |
| All PIN lesions | 6 | 4658.7 | 0.13 | 5 | 4628.2 | 0.11 | −19.2 (−393.8 to 69.7) |
| PIN grade 1 | 3 | 4666.1 | 0.06 | 4 | 4629.7 | 0.09 | 25.6 (−339.9 to 89.1) |
| PIN grade 2 or 3 | 3 | 4663.1 | 0.06 | 2 | 4628.6 | 0.04 | −48.9 (−1682.6 to 82.9) |
| Penile, perianal, or perineal cancer | 0 | 4670.6 | 0.00 | 0 | 4630.5 | 0.00 | — |
Data shown are for subjects who had at least one follow-up visit after day 1. EGL denotes external genital lesions with a diagnosis of condyloma acuminatum; HPV, human papillomavirus; and PIN, penile, perianal, or perineal intraepithelial neoplasia.
Subjects were counted once in each applicable category. A subject may have been included in more than one category.
There were 1653 heterosexual males and 290 males who had sex with male partners.
There were 115 cases of condylomata acuminata associated with any HPV type in the intention-to-treat population (32 in the vaccine group and 83 in the placebo group). Of these 115 cases, 20 involved subjects with biopsy specimens testing positive for more than 1 of the 14 HPV types tested (2 in the vaccine group and 18 in the placebo group).