Table 5.

Analysis of efficacy against HPV 6/11/16/18–related high-grade vulvar and vaginal lesions by categories of baseline covariates

Per-protocol populationIntention-to-treat population
Quadrivalent HPV vaccinePlaceboEfficacy, % (95% CI)Quadrivalent HPV vaccinePlaceboReduction, % (95% CI)
Cases/nRateCases/nRateCases/nRateCases/nRate
No. of sexual partners
    00/4640.01/5090.1100.0 (<0.0-100.0)0/5120.01/5550.1100.0 (<0.0-100.0)
    1-20/4,5140.014/4,5260.1100.0 (69.8-100.0)5/5,0670.025/5,0890.179.9 (46.6-94.0)
    ≥30/2,9220.08/2,8640.1100.0 (42.6-100.0)4/3,3720.017/3,3190.176.8 (28.9-94.3)
    Covariate by efficacy interactionP = 1.000P = 1.000
Age at start of vaccination (y)
    ≤170/1,0440.05/1,0610.2100.0 (<0.0-100.0)1/1,1380.010/1,1510.289.9 (28.7-99.8)
    18-200/3,2750.012/3,3320.1100.0 (63.4-100.0)3/3,7580.022/3,8160.286.2 (54.0-97.4)
    ≥210/3,5810.06/3,5090.1100.0 (16.7-100.0)5/4,0600.011/4,0020.155.1 (<0.0-87.8)
    Covariate by efficacy interactionP = 1.000P = 0.311
History of or day 1 abnormal Pap
    Normal0/6,7340.019/6,7410.1100.0 (78.6-100.0)5/7,5890.034/7,5850.185.3 (62.2-95.5)
    Abnormal0/8520.02/8180.1100.0 (<0.0-100.0)4/9960.15/9760.122.1 (<0.0-84.6)
    Covariate by efficacy interactionP = 1.000P = 0.053
Smoking history
    Without smoking history0/2,6170.08/2,7140.1100.0 (39.4-100.0)7/5,9460.026/5,8240.273.6 (37.5-90.3)
    With smoking history0/5,2820.015/5,1860.1100.0 (72.6-100.0)2/3,0040.017/3,1400.187.7 (48.3-98.6)
    Covariate by efficacy interactionP = 1.000P = 0.465
Hormonal contraception use
    No hormonal contraception at day 10/4,6880.012/4,6730.1100.0 (64.2-100.0)5/3,6490.023/3,6810.187.9 (40.7-93.4)
    Hormonal contraception at day 10/3,2020.011/3,2120.1100.0 (59.9-100.0)4/5,2890.020/5,2620.280.1 (40.7-95.1)
    Covariate by efficacy interactionP = 1.000P = 1.000

NOTE: Subjects are counted once in each applicable endpoint category. A subject may appear in more than one category. n is the number of subjects evaluable (i.e., number of subjects in the given population who also have at least one follow-up visit). “Rate” is the rate per 100 person-years at risk.