Investigators: Beth Arrowsmith, Camille Gibson, Christina Anthony, Fiona McDonald, Jan Jones, Jane Jones, Jennifer Gatens, Jennifer Kent, Krist Ewe, Lisa Montgomery, Nikki Schultz, Peter Richmond, Ushma Wadia
The MELODY Study is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if MEDI8897 will prevent medically attended Respiratory Syncytial Virus (RSV) -confirmed Lower Respiratory Tract Infection (LRTI) in healthy infants entering their first RSV season.
The population to be enrolled is healthy late preterm and term infants born ≥ 35 weeks 0 days gestational age who would not receive RSV prophylaxis (Palivizumab currently used in Australia for high risk infants) and are not eligible to receive Palivizumab based on current guidelines. Participants will be monitored throughout the study for LRTI and will attend 7 clinic visits with follow up through to 17 months post dose administration. Follow up will involve telephone contacts and protocol defined respiratory illness visits to evaluate LRTIs. VTG hopes to enrol 6-20 participants born from 1st November 2019, during the enrolment period 1st April to 31 May 2020.
Project partner: MedImmune