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Study to Evaluate the Safety and Efficacy of MEDI8897 for RSV

A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Parrimon, Yozandra

    Trial Phone: 321.841.5278 ; 321.841.1361

  • IRB No: 17.055.05

    Protocol Abbrev: MedImmune RSV

    Principal Investigator: Carlos E. Sabogal, MD

    Sub Investigators: Weatherly, Mark MD; Faverio, Luis MD; Garcia, Daniel MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: D5290C00003

    Treatment: Medication

    Applicable Disease Sites: Respiratory Syncytial Virus

    Therapies Involved: MEDI8897

  • Objective

    To assess the efficacy of MEDI8897 when administered as a single 50 mg IM dose to healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA and entering their first RSV season for the reduction of medically attended LRTI due to RT-PCR-confirmed RSV, compared to placebo.

  • Key Eligibility

    1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days Gestational Age
    2. Infants who are entering their first full RSV season at the time of screening