At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 762 enrolled
Drug / intervention
Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
In Brief
A Phase 3 clinical trial evaluating Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™) and Comparator: Comparator: Placebo (unspecified) for Rotavirus and Gastroenteritis. Completed, enrolled 762 participants.
Detailed Summary
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus, Gastroenteritis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartAug 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedJul 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago
Interventions
Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)biological
Rotateq orally administered 3 times
Comparator: Comparator: Placebo (unspecified)biological
Placebo orally administered 3 times