Evidence for efficacy in males 9 to 26 years | ||||||
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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 |