At a glance
ClinicalIndex Comparison Record- ✓Medically stable child with chronic lung disease of prematurity ≤24 months of age at randomization
- ✓OR child with premature birth (gestational age ≤35 weeks) who is 6 months of age or younger at randomization
- ✓Written informed consent from parent(s) or legal guardian(s)
- ✓Able to complete follow-up visit 4-6 months after last dose of study drug
- ✕Hospitalized at time of randomization (unless discharge anticipated within 3 weeks)
- ✕Receiving mechanical ventilation at study entry, including CPAP
- ✕Congenital heart disease, except uncomplicated CHD (e.g., PDA, small septal defect) or complicated CHD that is currently anatomically and hemodynamically normal
- ✕Mother with HIV infection unless child proven to be uninfected
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease
In Brief
A Phase 4 clinical trial evaluating Lyophilized Palivizumab and Liquid Palivizumab for Chronic Lung Disease. Completed, enrolled 417 participants across 54 sites.
Detailed Summary
The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.
Study Details
Timeline
Interventions
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.