Phase IIa Randomized, Double Blind, Controlled with GARDASIL™ Clinical Trial to Study the Tolerability and Immunogenicity of V505

Phase IIa Randomized, Double Blind, Controlled with GARDASIL™ Clinical Trial to Study the Tolerability and Immunogenicity of V505

Phase IIa Randomized, Double Blind, Controlled with GARDASIL™ Clinical Trial to Study the Tolerability and Immunogenicity of V505 (a multivalent Human papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Healthy 16 to 26 year old women.

Currently there are two HPV vaccines available that prevent infection of some HPV types:

1. GARDASIL® a vaccine developed by Merck Sharp & Dohme (Australia) Pty. Ltd. and manufactured by CSL. This vaccine provides protection against HPV types 6, 11, 16 & 18 and is currently available free for girls and women aged 9 to 26 years.   GARDASIL® will be used as the 'Control' vaccine in this study.
2. Cervarix*, developed by GlaxoSmithKline, provides protection against the infection of HPV types 16 & 18.

Merck Sharp & Dohme (Australia) Pty. Ltd. has developed a new vaccine called V505 which is designed to protect against 9 different types of HPV infection with are responsible for about 90 per cent of cervical cancers and 90 percent of genital warts.

This vaccine is similar to the GARDASIL® in that it contains proteins called VLPs that resemble different types of HPV to the body's immune system, but are not actually viruses. This is the first time this study vaccine (V505) has been tested in humans, however a vaccine with eight (8) of the VLPs has been tested in people and found to be generally well tolerated.

This study has been ongoing since 2007 and 25 subjects were recruited at this site. This study was completed in 2011.
 
Funders of the project.  Merck Sharp and Dohme