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Spots Global Cancer Trial Database for Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

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

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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