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Brief Title: Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Official Title: A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Study ID: NCT00122681
Brief Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description: NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
GSK Investigational Site, Birmingham, Alabama, United States
GSK Investigational Site, Fountain Valley, California, United States
GSK Investigational Site, San Diego, California, United States
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, Boulder, Colorado, United States
GSK Investigational Site, Boulder, Colorado, United States
GSK Investigational Site, Denver, Colorado, United States
GSK Investigational Site, Louisville, Colorado, United States
GSK Investigational Site, Clearwater, Florida, United States
GSK Investigational Site, Coral Gables, Florida, United States
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, West Palm Beach, Florida, United States
GSK Investigational Site, Augusta, Georgia, United States
GSK Investigational Site, Honolulu, Hawaii, United States
GSK Investigational Site, Iowa City, Iowa, United States
GSK Investigational Site, Arkansas City, Kansas, United States
GSK Investigational Site, Wichita, Kansas, United States
GSK Investigational Site, Wichita, Kansas, United States
GSK Investigational Site, Bardstown, Kentucky, United States
GSK Investigational Site, Louisville, Kentucky, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Omaha, Nebraska, United States
GSK Investigational Site, Lebanon, New Hampshire, United States
GSK Investigational Site, Morristown, New Jersey, United States
GSK Investigational Site, Albuquerque, New Mexico, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Poughkeepsie, New York, United States
GSK Investigational Site, Chapel Hill, North Carolina, United States
GSK Investigational Site, New Bern, North Carolina, United States
GSK Investigational Site, Cleveland, Ohio, United States
GSK Investigational Site, Tulsa, Oklahoma, United States
GSK Investigational Site, Portland, Oregon, United States
GSK Investigational Site, Carnegie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Erie, Pennsylvania, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Pittsburgh, Pennsylvania, United States
GSK Investigational Site, Austin, Texas, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Webster, Texas, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Charlottesville, Virginia, United States
GSK Investigational Site, Spokane, Washington, United States
GSK Investigational Site, Spokane, Washington, United States
GSK Investigational Site, Vancouver, Washington, United States
GSK Investigational Site, Wenatchee, Washington, United States
GSK Investigational Site, Sydney, New South Wales, Australia
GSK Investigational Site, Adelaide, South Australia, Australia
GSK Investigational Site, Hobart, Tasmania, Australia
GSK Investigational Site, Carlton, Melbourne, Victoria, Australia
GSK Investigational Site, Melbourne, Victoria, Australia
GSK Investigational Site, Perth, Western Australia, Australia
GSK Investigational Site, Brussels, , Belgium
GSK Investigational Site, Edegem, , Belgium
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Curitiba, Paraná, Brazil
GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, Brazil
GSK Investigational Site, Campinas, São Paulo, Brazil
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Langley, British Columbia, Canada
GSK Investigational Site, Winnipeg, Manitoba, Canada
GSK Investigational Site, St. John's, Newfoundland and Labrador, Canada
GSK Investigational Site, Truro, Nova Scotia, Canada
GSK Investigational Site, Oshawa, Ontario, Canada
GSK Investigational Site, Ottawa, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Waterloo, Ontario, Canada
GSK Investigational Site, Beauport, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Espoo, , Finland
GSK Investigational Site, Helsinki, , Finland
GSK Investigational Site, Helsinki, , Finland
GSK Investigational Site, Jarvenpaa, , Finland
GSK Investigational Site, Jyvaskyla, , Finland
GSK Investigational Site, Kerava, , Finland
GSK Investigational Site, Kotka, , Finland
GSK Investigational Site, Kouvola, , Finland
GSK Investigational Site, Kuopio, , Finland
GSK Investigational Site, Lahti, , Finland
GSK Investigational Site, Lappeenranta, , Finland
GSK Investigational Site, Mikkeli, , Finland
GSK Investigational Site, Oulu, , Finland
GSK Investigational Site, Pori, , Finland
GSK Investigational Site, Rauma, , Finland
GSK Investigational Site, Seinajoki, , Finland
GSK Investigational Site, Tampere, , Finland
GSK Investigational Site, Turku, , Finland
GSK Investigational Site, Vaasa, , Finland
GSK Investigational Site, Karlsruhe, Baden-Wuerttemberg, Germany
GSK Investigational Site, Ravensburg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Rheinstetten, Baden-Wuerttemberg, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Wuerzburg, Bayern, Germany
GSK Investigational Site, Dietzenbach, Hessen, Germany
GSK Investigational Site, Frankfurt, Hessen, Germany
GSK Investigational Site, Frankfurt, Hessen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz, Germany
GSK Investigational Site, Leipzig, Sachsen, Germany
GSK Investigational Site, Nordhausen, Thueringen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Modena, Emilia-Romagna, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Cuenavaca, Morelos, Mexico
GSK Investigational Site, Cavite, , Philippines
GSK Investigational Site, Laguna, , Philippines
GSK Investigational Site, Las Pinas City, , Philippines
GSK Investigational Site, Los Banos, Laguna, , Philippines
GSK Investigational Site, Makati City, , Philippines
GSK Investigational Site, Manila, , Philippines
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, L'Hospitalet de Llobregat, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Marid, , Spain
GSK Investigational Site, Móstoles, , Spain
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Bangkok, , Thailand
GSK Investigational Site, Bangkok, , Thailand
GSK Investigational Site, Bangkok, , Thailand
GSK Investigational Site, Aberdeen, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Manchester, , United Kingdom
GSK Investigational Site, Manchester, , United Kingdom
GSK Investigational Site, Waterloo, Liverpool, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR