Sanofi Pasteur MSD reported today that Merck's investigational 9-valent Human Papilloma Virus (HPV) vaccine, V503, prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by five additional HPV types in its pivotal Phase III efficacy study.
The study also showed that V503 generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Gardasil. The frequencies of adverse event reports were also generally comparable between V503 and Gardasil.
Merck's investigational 9-valent HPV vaccine includes five more HPV types (31, 33, 45, 52, 58) in addition to the four original HPV types in its Gardasil vaccine (6, 11, 16, 18). The vaccine is being developed to provide protection against 9 types of the HPV virus that are known to cause HPV related cervical/genital cancers. The vaccine's efficacy against these additional virus types is a major step in the battle against HPV-related disease.
"In the Phase III studies being presented for the first time, V503 prevented approximately 97 percent of high-grade cervical, vulvar and vaginal diseases caused by five additional HPV types," said study investigator Elmar Joura, M.D., Associate Professor of Gynecology and Obstetrics, Medical University of Vienna and Comprehensive Cancer Center, Vienna, Austria.
These data, along with results of two other Phase III studies, are being presented for the first time at the EUROGIN congress (European Research Organization on Genital Infection and Neoplasia) in Florence, Italy on Tuesday 5 November 2013.
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