Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
NCT ID: NCT00925288
Last Updated: 2012-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2009-10-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Regular schedule
Duration: Gardasil HPV vaccine administered intramuscularly at 0,2,6 months
Gardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Modified Schedule
Duration: Gardasil HPV vaccine administered intramuscularly at 0,3,6 months
Gardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Interventions
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Gardasil
Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Registered female sex worker living in Lima
* Healthy with no known immune deficiency
* Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
* Willing to provide informed consent
Exclusion Criteria
* Known immune deficiency disorder
* Current receipt of immunosuppressive drugs
* Allergy to yeast or known contraindication to HPV vaccine
* Women who have had their cervix removed
* Previous HPV vaccination
* Current fever over 100 degrees Fahrenheit
18 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
NGO Via Libre
OTHER
Universidad Peruana Cayetano Heredia
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Neal Halsey
Professor of International Health
Principal Investigators
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Neal Halsey, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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NGO Via Libre
Lima, Lima Province, Peru
Countries
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References
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Other Identifiers
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IRB00001625
Identifier Type: -
Identifier Source: secondary_id
Merck IISP 35706
Identifier Type: -
Identifier Source: org_study_id