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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00481767 |
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine 580299 in female subjects aged 10-25 years enrolled in Africa.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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HPV-16/18 Infections Cervical Neoplasia |
Biological: HPV-16/18 L1 VLP AS04 (580299) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIIb Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered in Healthy Adolescent and Adult Female Subjects. |
Estimated Enrollment: | 666 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 10 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Senegal | |
GSK Clinical Trial Call Center | Recruiting |
Dakar, Senegal | |
Contact: GSK Clinical Trial Call Center 1-877-379-3718 | |
Tanzania | |
GSK Clinical Trial Call Center | Not yet recruiting |
Mwanza, Tanzania | |
Contact: GSK Clinical Trial Call Center 1-877-379-3718 |
Study Director: | Clinical Trial | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 106069 |
Study First Received: | May 31, 2007 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00481767 |
Health Authority: | Senegal: Ministere de la sante |
HPV; Cervical cancer; Papillomavirus; Human papillomavirus (HPV) vaccine |
Healthy |
Infection |