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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00426361 |
Infection with human papillomavirus (HPV) has been clearly established as the central 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, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' HPV-16/18 L1 AS04 vaccine (580299) as compared to the administration of either vaccine alone.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
Papillomavirus Infections Cervical Neoplasia |
Biological: HPV-16/18 L1 AS04 (580299) Biological: Boostrix Polio (dTpa-IPV) |
Phase III |
MedlinePlus related topics: | Cancer Polio and Post-Polio Syndrome |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-Administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years |
Estimated Enrollment: | 750 |
Study Start Date: | February 2007 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
GSK Clinical Trials Call Center | |||||
Paris, France | |||||
Germany | |||||
GSK Clinical Trials Call Center | |||||
Berlin, Germany | |||||
Spain | |||||
GSK Clinical Trials Call Center | |||||
Madrid, Spain |
GlaxoSmithKline |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 108464 |
First Received: | January 23, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00426361 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
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