Table 2.

Vaccine efficacy against HPV 6–, 11–, 16–, and 18–related high-grade cervical lesions (CIN 2 or worse) 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
        CIN 2 or worse7,86420.07,8651100.598.2 (93.3-99.8)
            CIN 27,86400.07,865710.3100.0 (94.7-100.0)
            CIN 3 or worse7,86420.07,865660.397.0 (88.7-99.6)
                CIN 37,86420.07,865630.396.8 (88.1-99.6)
                AIS7,86400.07,86570.0100.0 (30.9-100.0)
    By HPV type
        HPV 66,90200.06,828120.1100.0 (64.5-100.0)
        HPV 116,90200.06,82840.0100.0 (<0-100.0)
        HPV 166,64720.06,455810.497.6 (91.1-99.7)
        HPV 187,38200.07,316290.1100.0 (86.6-100.0)
Intention-to-treat
    By lesion severity
        CIN 2 or worse8,8231420.58,8602931.051.5 (40.6-60.6)
            CIN 28,823810.38,8601830.655.7 (42.2-66.4)
            CIN 3 or worse8,8231040.38,8601950.646.6 (32.0-58.3)
                CIN 38,8231020.38,8601860.645.1 (29.8-57.3)
                AIS8,82360.08,860150.060.0 (<0-87.3)
    By HPV type
        HPV 68,82320.08,860230.191.3 (64.8-99.0)
        HPV 118,82300.08,86060.0100.0 (15.0-100.0)
        HPV 168,8231320.48,8602430.845.7 (32.6-56.4)
        HPV 188,82390.08,860600.285.0 (69.6-93.5)

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.

Abbreviation: CIN, cervical intraepithelial neoplasia.