At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,036 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.
Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
In Brief
An observational study for Severe Respiratory Syncytial Virus Infection. Completed, enrolled 2,036 participants across 37 sites in 10 countries.
Detailed Summary
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, France, Germany, Italy, Norway, Poland, Slovenia, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
Primary CompletionJan 2010
First PostedFeb 2010
TodayJul 2026
First PostedFeb 25, 2010
Enrollment StartJul 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.4 years ago