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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00652938 |
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine as compared to the administration of either vaccine alone.
Condition | Intervention | Phase |
---|---|---|
Human Papillomavirus Infection |
Biological: Engerix B Biological: HPV Vaccine (GSK580299) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) co-Administrated With a Commercially Available Vaccine in Healthy Female Adolescents |
Estimated Enrollment: | 756 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Biological: HPV Vaccine (GSK580299)
IM administration
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B: Experimental |
Biological: Engerix B
IM administration
Biological: HPV Vaccine (GSK580299)
IM administration
|
C: Active Comparator |
Biological: Engerix B
IM administration
|
Ages Eligible for Study: | 9 Years to 15 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
GSK Investigational Site | |
ROTTERDAM, Netherlands, 3011 EN | |
GSK Investigational Site | |
NIJMEGEN, Netherlands, 6525 GA | |
Sweden | |
GSK Investigational Site | |
SKENE, Sweden, SE-511 62 | |
GSK Investigational Site | |
MALMÖ, Sweden, SE-211 52 | |
GSK Investigational Site | |
NORRKÖPING, Sweden, SE-601 82 | |
GSK Investigational Site | |
LULEÅ, Sweden, SE-972 31 | |
GSK Investigational Site | |
LINKÖPING, Sweden, SE-581 85 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111507 |
Study First Received: | March 27, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00652938 |
Health Authority: | Sweden: Medical Products Agency |
HPV vaccine Co-administration Cervical cancer |
Virus Diseases Skin Diseases, Infectious Warts Skin Diseases |
DNA Virus Infections Papillomavirus Infections Healthy |
Skin Diseases, Viral Neoplasms Tumor Virus Infections Infection |