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Sponsors and Collaborators: |
GlaxoSmithKline MedImmune LLC |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00689741 |
The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.
Condition | Intervention | Phase |
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Papillomavirus Infections |
Biological: Cervarix Biological: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil. |
Enrollment: | 1113 |
Study Start Date: | January 2001 |
Study Completion Date: | April 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Biological: Cervarix
3 doses of IM injection
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B: Placebo Comparator |
Biological: placebo
3 doses of IM injection of Al(OH)3 placebo
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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:
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 580299/001 |
Study First Received: | May 30, 2008 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00689741 |
Health Authority: | United States: Food and Drug Administration |
HPV vaccine |
Virus Diseases DNA Virus Infections Papillomavirus Infections Healthy |
Communicable Diseases Tumor Virus Infections Infection |