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

  • STATUS
    Recruiting
  • End date
    Dec 3, 2021
  • participants needed
    1500
  • sponsor
    MedImmune LLC
Updated on 25 July 2021
chronic disease
diuretics
bronchodilator
palivizumab

Summary

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.

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).

Details
Condition Respiratory syncytial virus infection, rsv infection
Treatment Palivizumab, MEDI8897
Clinical Study IdentifierNCT03959488
SponsorMedImmune LLC
Last Modified on25 July 2021

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