At a glance
ClinicalIndex Comparison RecordN/ACompleted· 118 enrolled
Drug / intervention
Motavizumab +1 morebiological
Likely dose
Motavizumab 30 mg/kgfrom 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 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
In Brief
A clinical study evaluating Motavizumab and Placebo for RSV Illness in ≤12 Months of Participants. Completed, enrolled 118 participants across 35 sites in 5 countries.
Detailed Summary
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Chile, New Zealand, Panama, United States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionSep 2009
TodayJul 2026
First PostedJan 11, 2007
Enrollment StartJan 10, 2007
Primary CompletionSep 17, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.5 years ago
Interventions
Motavizumabbiological
A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.
Placeboother
A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.