Last updated on December 2019

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

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Brief description of study

The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.

Detailed Study Description

This study is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety, pharmacokinetics (PK), anti-drug antibody (ADA) response, and descriptive efficacy for MEDI8897 in high-risk infants eligible to receive palivizumab when entering their first or second RSV season (Season 1 or Season 2, respectively). Approximately 1,500 palivizumab-eligible infants entering their first RSV season will be enrolled into one of 2 cohorts : (1) preterm cohort, including approximately 750 preterm infants ( 35 weeks GA) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 750 infants with CLD of prematurity or hemodynamically significant CHD. As minimum of 100 infants with hemodynamically significant CHD will be enrolled. Within each cohort, randomization will be stratified by hemisphere (northern, southern) and subject age at the time of Season 1 randomization ( 3 months, > 3 to 6 months, > 6 months).