GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], the cervical cancer vaccine from Merck & Co., Inc., prevented 90 percent of external genital lesions caused by human papillomavirus (HPV) types 6, 11, 16 and 18 in a pivotal Phase III study in men aged 16 to 26.
These are the only data evaluating efficacy of any HPV vaccine in preventing disease in males, and were presented for the first time this week at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference.
The initial planned analysis of this study, an analysis of male study participants aged 16 to 26 who had not been infected with at least one of the four HPV types before the start of the study through one month after receiving their third dose of the vaccine or placebo, has been completed. This analysis was predetermined in the study protocol to be conducted after at least 32 cases of external genital lesions were observed. The study is ongoing, and additional data will be submitted to global regulatory agencies once available.
Merck remains on track to submit a supplemental Biologics License Application for GARDASIL to the U.S. Food and Drug Administration by the end of 2008 for the use of GARDASIL in boys and men ages 9 to 26 for the prevention of external genital lesions caused by HPV types 6, 11, 16 and 18. Other regulatory submissions around the world will occur as planned.
GARDASIL is not currently approved for males in the United States. GARDASIL is indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
Source: Merck & Co., Inc., USA