Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
NCT ID: NCT00718237
Last Updated: 2017-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
762 participants
INTERVENTIONAL
2008-08-31
2009-08-31
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
RotaTeq™
Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Rotateq orally administered 3 times
2
Placebo
Comparator: Comparator: Placebo (unspecified)
Placebo orally administered 3 times
Interventions
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Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Rotateq orally administered 3 times
Comparator: Comparator: Placebo (unspecified)
Placebo orally administered 3 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
6 Weeks
12 Weeks
ALL
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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Iwata S, Nakata S, Ukae S, Koizumi Y, Morita Y, Kuroki H, Tanaka Y, Shizuya T, Schodel F, Brown ML, Lawrence J. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013 Aug;9(8):1626-33. doi: 10.4161/hv.24846. Epub 2013 May 31.
Other Identifiers
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2008_014
Identifier Type: -
Identifier Source: secondary_id
V260-029
Identifier Type: -
Identifier Source: org_study_id
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