Trial Number

963-19

Condition

Respiratory Syncytial Virus (RSV)

Participant Age Range

Preterm infants (with less than 35 weeks gestational age) and children under 24 months

Participant Gender

Any

Enrolling Participants

No

Overview

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 (MEDLEY)

Prevention of RSV illnesses in all infants is a major public health priority; however, despite more than 50 years of attempted vaccine development, there are no licensed vaccines. While RSV prevention exists in the form of a specific RSV IgG (Synagis®, palivizumab) requiring 5 once-monthly injections, it is licensed only for infants who experience the greatest morbidity and mortality from RSV: preterm infants born = 35 weeks Gestational Age (GA), children with chronic lung disease (CLD) of prematurity, and children with hemodynamically significant congenital heart disease (CHD). Because of the significant advantage of one dose per RSV season that MEDI8897 would provide, MedImmune recognizes the potentially important benefits for the current pediatric population receiving palivizumab who must receive monthly injections during the typical 5-month RSV season for protection. Therefore, this Phase 2/3 study is planned to support an indication in the high-risk palivizumab-eligible population entering their first and second RSV seasons to compare MEDI8897 once-per-RSV-season dosing with palivizumab once-per-month dosing during the RSV season.

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