At a glance
ClinicalIndex Comparison RecordN/ACompleted· 3,798 enrolled
Drug / intervention
Not specified
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.
Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
In Brief
An observational study for Gastroenteritis Rotavirus. Completed, enrolled 3,798 participants.
Detailed Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis Rotavirus
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedFeb 2010
Primary CompletionJun 2013
TodayJul 2026
First PostedFeb 24, 2010
Enrollment StartSep 1, 2007
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.4 years ago