Gardasil™: Vaccine efficacy against external genital lesions (vulval and vaginal intra-epithelial neoplasia and genital warts)
| Population | Endpoint | GARDASIL™ cases | Placebo cases | % Efficacy | % CI | p-Value |
|---|---|---|---|---|---|---|
| (http://www.cdc.gov/nip/acip/slides/jun06/hpv-2-barr.pdf) | ||||||
| Per protocol (PPE) and HN-MITT (HPV-negative modified intention to treat): endpoint HPV6/11/16/18-related external genital lesions (EGL) | ||||||
| PPE | HPV6/11/16/18-EGL | 0 | 40 | 100 | 88,100 | <0.001 |
| HPV6-related EGL | 0 | 23 | 100 | 83,100 | ||
| HPV11-related EGL | 0 | 10 | 100 | 55,100 | ||
| HPV16-related EGL | 0 | 10 | 100 | 56,100 | ||
| HPV18-related EGL | 0 | 3 | 100 | <0,100 | ||
| HN-MITT | HPV6/11/16/18-EGL | 3 | 59 | 95 | 84,99 | |