Evidence for cross-protective efficacy against non-vaccine types in females ages 16 to 26 years | ||||||
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STUDY DETAILS | SUMMARY | |||||
Study | Vaccine | Study Design | Participants | Summary of Key Findings | Level of Evidence | Quality |
Brown et al. (86) | Gardasil® | Randomized, double-blind, placebo controlled trial Combined database of two phase III efficacy trials (FUTURE I and II) |
n=17, 622 Exclusions: history of abnormal Pap test or treatment for genital warts |
Reduction in incidence of HPV type 31/45 infection by 40.3% in vaccinated group (95% CI: 13.9-59.0); C1N1-3/AIS reduction of 43.6% (95% CI: 12.9-64.1) Reduction in incidence of HPV type 31/33/45/52/58 infection by 25.0% in vaccinated group (95% CI: 5.0-40.9); C1N1-3/AIS reduction of 29.2% (95% CI: 8.3-45.5) Efficacy for C1N2-3.AIS (high-grade lesions) associated with 10 non-vaccine types (31/33/35/39/45/51/52/56/58/59) was 32.5% (95% CI: 6.0-51.9) |
Level I | Good |
Wheeler et al. (87) | Gardasil® | Randomized, double-blind, placebo controlled trial Combined database of two phase III efficacy trials (FUTURE I and II) |
n=17, 622 | Significant reduction in rate of HPV types 31, 33, 45, 52 and 58 infection of 17.7% (95% CI:5.1-28.7) and CIN1-3/AIS of 18.8% (95% CI:7.4-28.9) Reduction in the rate of HPV type 31, 58, 59-related CIN1-3/AIS of 26.0% (95% CI: 6.7-41.4), 28.1% (95% CI: 5.3-45.6) and 37.6% (95% CI: 6.0-59.1) respectively |
Level I | Good |