At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
MEDI3250drug
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 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
In Brief
A Phase 3 clinical trial evaluating MEDI3250 for Healthy Japanese Children Age 2 Years Through 6 Years. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartNov 2014
Primary CompletionFeb 2015
TodayJul 2026
First PostedOct 21, 2014
Enrollment StartNov 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.7 years ago
Interventions
MEDI3250drug
MEDI3250