The interim report (mean duration?=?29?months) demonstrated that the quadrivalent HPV vaccine was 90��4% effective in reducing external genital lesions (P?<?0��001) and 89��4% effective in preventing genital warts (P value not reported). More injection-site events were reported among patients in the vaccine group compared with those in the placebo group, and there were no reports of serious adverse events. This trial is ongoing, initially designed as a 36-month follow-up study. Any additional results will be submitted to the FDA once available (15). Although efficacy trials are underway in males, there is currently limited long-term efficacy data available. The European Commission, Mexico and Australia have licensed the quadrivalent vaccine for men; and in October 2009 the FDA expanded the labelling indications of the quadrivalent <a href="http://www.selleck.cn/products/MS-275.html
">MS-275 HPV vaccine to include the prevention of HPV types 6 and 11-related genital warts in males aged 9�C26 years (12). The Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE Olaparib cost
I) study was a phase III, randomized, double-blind, placebo-controlled, international trial that assessed the incidence of genital warts, vulvar or cervical intraepithelial neoplasia (CIN) or cancer, and the incidence of CIN, adenocarcinoma in situ (AIS) or cancer associated with HPV type 6, 11, 16 or 18. A total of 5455 women aged 16�C24?years with no history of genital warts or abnormal cervical cytology screenings and ��4 lifetime sexual partners were assigned to active vaccine (n?=?2723) or placebo (n?=?2732) and were monitored for up to an average of 3?years after vaccination. Vaginal, vulvar, perineal and perianal intraepithelial lesions or warts were prevented via the HPV vaccine, showing 100% effectiveness against the four HPV subtypes, compared with 60 placebo-related cases (95% CI, 94�C100). Analyses conducted on the per-protocol, susceptible population showed that the vaccine was also 100% effective (n?=?2241) in preventing CIN (grades 1�C3) or AIS compared with the 65 cases (n?=?2258) in the placebo group (95% CI, 94�C100). Analyses conducted on selleck inhibitor
the unrestricted susceptible population (USP) [negative polymerase chain reaction (PCR) and serologic testing at enrollment] yielded a 95% vaccine efficacy rate for any grade external anogenital or vaginal lesions (four vaccine-treated cases vs. 81 placebo-treated cases), 98% efficacy for all grades of cervical lesions (two vaccine-treated cases vs. 89 placebo-treated cases), 91% efficacy for high grade vulvar or vaginal lesions (one vaccine-treated case vs. 11 placebo-treated cases) and 100% efficacy for AIS (zero vaccine-treated cases vs. 6 placebo-treated cases) (20).