Table 4.

Vaccine efficacy against HPV 6–, 11–, 16–, and 18–related high-grade vulvar and vaginal lesions through the end of the study (protocols 007, 013, and 015) by severity and HPV type

Quadrivalent HPV vaccine (N = 9,075)Placebo (N = 9,075)Observed efficacy, % (95% CI)
nCasesRatenCasesRate
Per-protocol
    By lesion severity
        VIN 2/3, VaIN 2/3 or worse7,90000.07,902230.1100.0 (82.6-100.0)
            VIN 2/37,90000.07,902130.1100.0 (67.2-100.0)
            VaIN 2/37,90000.07,902100.0100.0 (55.4-100.0)
    By HPV type
        HPV 66,93200.06,85660.0100.0 (15.8-100.0)
        HPV 116,93200.06,85610.0100.0 (<0-100.0)
        HPV 166,65400.06,467170.1100.0 (76.5-100.0)
        HPV 187,41400.07,34320.0100.0 (<0-100.0)
Intention-to-treat
    By lesion severity
        VIN2/3, VaIN2/3 or worse8,95690.08,969430.179.0 (56.4-91.0)
            VIN2/38,95680.08,969300.173.3 (40.3-89.4)
            VaIN2/38,95620.08,969140.085.7 (37.6-98.4)
    By HPV type
        HPV 68,95610.08,96990.088.9 (19.5-99.7)
        HPV 118,95600.08,96920.0100.0 (<0-100.0)
        HPV 168,95680.08,969360.177.7 (51.2-91.1)
        HPV 188,95610.08,96930.066.5 (<0-99.4)

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 randomized to the respective vaccination group who received at least one injection; 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.

Abbreviations: VIN, vulvar intraepithelial neoplasia; VaIN, vaginal intraepithelial neoplasia.