Merck & Co., Inc., prevented 100 percent of high-grade cervical pre-cancers and non-invasive cervical cancers (CIN 2/3 and AIS) associated with human papillomavirus (HPV) types 16 and 18 in a new phase III study. The analysis compared GARDASIL to placebo in women who were not infected with HPV 16 and 18 at enrollment and who remained free of infection through the completion of the vaccination regimen. Women were followed for an average of two years after enrollment. Tomorrow these data will be presented for the first time at the Infectious Diseases Society of America (IDSA) annual meeting.
This trial is part of the ongoing phase III program for GARDASIL, which involves over 25,000 people in 33 countries worldwide. Merck remains on track to submit a Biologics License Application for GARDASIL to the Food and Drug Administration in the fourth quarter of 2005. More than 12,000 women from 13 countries participated in this trial.
This phase III study, titled FUTURE II, is a prospective, randomized, double-blind, placebo-controlled study with two vaccination groups. Women aged 16 to 26 years were randomized to receive a three-dose regimen of either GARDASIL or placebo at Day 1, Month 2, and Month 6. A total of 12,167 women were enrolled from 90 study centers in Brazil, Colombia, Denmark, Finland, Iceland, Mexico, Norway, Peru, Poland, Singapore, Sweden, the United Kingdom and the United States (including Puerto Rico) and were equally allocated between the two groups. A group of 6,082 females received GARDASIL and another group of 6,075 received placebo.
FUTURE II evaluated the incidence of HPV 16/18-related cervical pre-cancers known as CIN (cervical intraepithelial neoplasia) 2/3 and non-invasive cancers. CIN 2 is a moderate-grade lesion of the cervix. CIN 3 represents both high-grade lesions an
Contact: Jennifer Mallory
Edelman Public Relations