Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1021 participants
INTERVENTIONAL
2006-06-12
2009-09-16
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
Study Groups
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1
Placebo
Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen
2
Vaccine
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Interventions
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Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With 1-4 Lifetime Sexual Partners
Exclusion Criteria
18 Years
26 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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Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
Other Identifiers
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2006_032
Identifier Type: -
Identifier Source: secondary_id
V501-027
Identifier Type: -
Identifier Source: org_study_id
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