ARTICLE | Clinical News

Gardasil: Phase III data

February 22, 2010 8:00 AM UTC

Data from a double-blind Phase III trial in 595 men ages16-26 who have sex with men showed that Gardasil was 77.5% effective in preventing AIN associated with HPV types 6, 11, 16 and 18 and anal cancer vs. placebo at 2.5 years post-dose 3. Specifically, 5 cases of HPV type 6, 11, 16 or 18-related AIN occurred in the Gardasil group compared with 24 cases for placebo. No cases of anal cancer occurred in either group and no vaccine-related serious adverse events were reported. Subjects received Gardasil or placebo at enrollment, 2 months and 6 months. Data were presented at the European Research Organization on Genital Infection and Neoplasia meeting in Monte Carlo. ...