D5290C00004 MELODY, MEDI8897 for RSV in infants
Research type
Research Study
Full title
A Phase 3 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 Late Preterm and Term Infants (MELODY)
IRAS ID
269249
Contact name
Saul Faust
Contact email
Sponsor organisation
MedImmune, LLC
Eudract number
2019-000114-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
118524, IND
Duration of Study in the UK
4 years, 0 months, 2 days
Research summary
The purpose of this study is to evaluate how effective a drug called MEDI8897 (an antibody product, similar to a vaccine) is at preventing lung disease caused by Respiratory Syncytial Virus (RSV) and to evaluate the safety and tolerability of MEDI8897 in late preterm and term infants in their first year of life compared with placebo (a saline solution that looks like the study drug but does not contain the active ingredient).
MEDI8897 it is a type of antibody called a monoclonal antibody (an antibody produced by a single clone of cells or cell line and consisting of identical antibody molecules) that is made in the laboratory and acts against RSV. MEDI8897 is designed to extend the time the antibody is active in the body against RSV. It is expected that MEDI8897 can be given once to provide protection against RSV for the entire 5 months of the RSV season. A medicine like MEDI8897 that requires fewer doses could be used to prevent RSV in all infants.
The entire study is planned to go on for approximately 3 and a half years. The study will include around 3000 healthy late preterm and term infants. Sites in approximately 32 countries will participate in the study, and each child is expected to participate for 17 months.
The study consists of a Screening period (up to 30 days), a Treatment period (1 dosing day) and a Follow-Up period, including phone calls (16 months).
Participants will be randomly assigned in a 2:1 ratio to receive a single dose of MEDI8897 or placebo. The MEDI8897 dose level (either 50 mg or 100 mg) will be decided upon the participants body weight at time of dosing.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0415
Date of REC Opinion
4 Sep 2019
REC opinion
Favourable Opinion