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- (MEDLEY) A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children
Clinical Trial
(MEDLEY) A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children
This study is to test how safe and effective a new vaccine is for infants. It is a drug to prevent RSV (Respiratory Syncytial Virus) in high-risk neonates.
Eligibility Criteria
- Inclusion Criteria: 1. Perterm infants with a diagnosis of Chronic Lung Disease of Prematurity or with Congenital Heart Defect who are entering their first RSV season Exclusion Criteria: 1. Any fever (equal or greater than 100.4°F [38.0°C], regardless of route) or acute illness within 7 days prior to randomization. 2. Infant has or has had a Lower Respiratory Tract Infection (LRTI), or has or has had RSV, or has health problems that leads the investigator believe participation in this study would not be in the best interests of the infant or of the study. 3. Children of employees of the sponsor or Augusta University
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