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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00552279 |
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
HPV-16/18 Infections and Cervical Neoplasia |
Biological: GSK580299 |
Phase III |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years |
Estimated Enrollment: | 800 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: GSK580299
HPV vaccine
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2 |
Biological: GSK580299
HPV vaccine
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Ages Eligible for Study: | 15 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Italy | |||||
GSK Clinical Trials Call Center | |||||
Cagliari, Italy, 09127 | |||||
GSK Clinical Trials Call Center | |||||
Catania, Italy, 95126 | |||||
GSK Clinical Trials Call Center | |||||
Lodi, Italy, 26900 | |||||
GSK Clinical Trials Call Center | |||||
Ragusa, Italy, 97100 | |||||
GSK Clinical Trials Call Center | |||||
Palermo, Italy, 90127 | |||||
GSK Clinical Trials Call Center | |||||
Perugia, Italy, 6122 | |||||
GSK Clinical Trials Call Center | |||||
Milano, Italy, 20122 | |||||
GSK Clinical Trials Call Center | |||||
Sassari, Italy, 07100 | |||||
Romania | |||||
GSK Clinical Trials Call Center | |||||
Sibiu, Romania, 550166 | |||||
GSK Clinical Trials Call Center | |||||
Bucharest, Romania, 22102 | |||||
GSK Clinical Trials Call Center | |||||
Cluj, Romania, 400217 | |||||
Romania, Ilfov | |||||
GSK Clinical Trials Call Center | |||||
Voluntari, Ilfov, Romania, 77190 | |||||
Slovakia | |||||
GSK Clinical Trials Call Center | |||||
Trencin, Slovakia, 911 01 | |||||
GSK Clinical Trials Call Center | |||||
Nova Dubnica, Slovakia, 018 51 | |||||
GSK Clinical Trials Call Center | |||||
Dolny Kubin, Slovakia, 026 01 |
GlaxoSmithKline |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 109179 |
First Received: | October 30, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00552279 |
Health Authority: | Italy: AIFA - Italian Ministry of Health; United States: Food and Drug Administration |
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