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.
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).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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