At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
palivizumabbiological
Likely dose
palivizumab 15 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 Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation
In Brief
A Phase 3 clinical trial evaluating palivizumab for Respiratory Syncytial Virus Infection and 3 related conditions. Completed, enrolled 100 participants across 19 sites.
Detailed Summary
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionApr 2010
Study CompletionJul 2010
TodayJul 2026
First PostedNov 3, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.7 years ago
Interventions
palivizumabbiological
palivizumab 15 mg/kg intramuscularly