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Spots Global Cancer Trial Database for Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

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Trial Identification

Brief Title: Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

Official Title: Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

Study ID: NCT00541970

Interventions

Cervarix
Placebo

Study Description

Brief Summary: Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Detailed Description:

Eligibility

Minimum Age: 9 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

GSK Investigational Site, Edmonton, Alberta, Canada

GSK Investigational Site, Langley, British Columbia, Canada

GSK Investigational Site, St. John's, Newfoundland and Labrador, Canada

GSK Investigational Site, Truro, Nova Scotia, Canada

GSK Investigational Site, Quebec City, Quebec, Canada

GSK Investigational Site, Karlsruhe, Baden-Wuerttemberg, Germany

GSK Investigational Site, Kehl, Baden-Wuerttemberg, Germany

GSK Investigational Site, Rheinstetten, Baden-Wuerttemberg, Germany

GSK Investigational Site, Tauberbischofsheim, Baden-Wuerttemberg, Germany

GSK Investigational Site, Muenchen, Bayern, Germany

GSK Investigational Site, Weilheim, Bayern, Germany

GSK Investigational Site, Wuerzburg, Bayern, Germany

GSK Investigational Site, Frankfurt, Hessen, Germany

GSK Investigational Site, Hannover, Niedersachsen, Germany

GSK Investigational Site, Hannover, Niedersachsen, Germany

GSK Investigational Site, Wolfenbuettel, Niedersachsen, Germany

GSK Investigational Site, Trier, Rheinland-Pfalz, Germany

GSK Investigational Site, Leipzig, Sachsen, Germany

GSK Investigational Site, Flensburg, Schleswig-Holstein, 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

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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