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. 2012 Jan 2;38(ACS-1):1–62. doi: 10.14745/ccdr.v38i00a01
Evidence for efficacy in males 9 to 26 years
STUDY DETAILS SUMMARY
Study Vaccine Study Design Participants Summary of Key Findings Level of Evidence Quality
Guiliano et al. (88) Gardasil® Randomized, double-blind, placebo-controlled
Three doses at 0, 2 and 6 months
36 month follow-up (30.1 month mean for these results)
Protocol 020
n=4065 males
Heterosexual males 16 to 23 years (n=3463);
MSM 16 to 26 years (n=602)
EGL (external genital lesion) efficacy 90.4% (95% CI: 69.2-97.9)
Type-specific EGL efficacy: Types 6, 11, 16, and 18:
84.3% (95% CI: 46.5-97.0),
90.9% (95% CI: 37.7-99.8),
100% (95% CI: 0-100),
100% (95% CI: <0-100)
Efficacy against condyloma and PPPIN (penile/perianal/perineal intraepithelial neoplasia) 89.4% (95% CI: 65.5-97.9)
Level I Good
Palefsky et al. (153) Gardasil® Efficacy against persistent infection: 85.6% (95% CI: 75.1-92.2)
Efficacy against persistent infection from individual HPV types 6, 11, 16 and 18 88.0% (95% CI: 66.3-96.9), 93.4% (95% CI: 56.8-99.8), 78.7% (95% CI: 55.5-90.9), 96.0% (95% CI: 75.6-99.9) respectively.
Efficacy against infection at ≥1 visit: 44.7% (95% CI: 31.5-55.6)
Level I Assessment pending peer-reviewed publication