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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00799825 |
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).
Condition | Intervention | Phase |
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Human Papillomavirus (HPV) Type 16/18 Infections and Cervical Neoplasia. |
Biological: GSK580299, GSK Biological's HPV vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment, Safety Study |
Official Title: | Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008 |
Estimated Enrollment: | 1200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HPV vaccine group: Experimental
Canadian and American subjects who previously received the Hepatitis A control vaccine in the primary study (NCT00122681) will receive the GSK 580299 HPV vaccine in the current study.
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Biological: GSK580299, GSK Biological's HPV vaccine
All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111955 |
Study First Received: | November 26, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00799825 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HPV cervical cancer papillomavirus human papillomavirus HPV vaccine |