Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
NCT ID: NCT00517309
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1877 participants
INTERVENTIONAL
2001-12-28
2004-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Eligibility Criteria
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Inclusion Criteria
* Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
Exclusion Criteria
* History of hepatitis B infection
* History of vaccination with hepatitis B vaccine
* History of genital warts or treatment for genital warts
16 Years
23 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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2007_576
Identifier Type: -
Identifier Source: secondary_id
V501-011
Identifier Type: -
Identifier Source: org_study_id
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