D5290C00003 - MEDI8897 Against RSV in Healthy Preterm Infants
Research type
Research Study
Full title
A Phase 2b Randomised, 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
IRAS ID
210405
Contact name
Louisa Vass
Contact email
Sponsor organisation
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
Eudract number
2016-001677-33
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
MEDI8897 is being developed to protect infants from getting serious lower respiratory tract infection caused by respiratory syncytial virus (RSV). RSV is present in the general population from late Autumn to early Spring. Infection with RSV is very common in children. In the first year of life, about half of all infants become infected with RSV. RSV typically causes a cold-like illness in older children and adults, but can cause serious lung disease in infants and young children which may require medical attention such as outpatient and emergency department visits or hospitalisation. Preterm infants are at high risk for having serious illness from RSV infection.
MEDI8897 is a type of monoclonal antibody. This is a man-made drug that works in the same way as antibodies produced by the body’s own immune system to infections or vaccines. MEDI8897 is not manufactured from blood but is artificially manufactured.
This study is being done in healthy preterm infants born between 29 weeks and 35 weeks’ gestational age who are up to 8 months old and entering their first full RSV season. The purpose of this study is to evaluate how effective MEDI8897 is at preventing lung disease caused by RSV and to evaluate the safety and tolerability of MEDI8897 in healthy preterm infants compared with placebo (a saline solution that looks like the study drug but does not contain any active ingredient). The study will also measure drug levels of MEDI8897 in the blood, as well as looking at days missed from daycare and work by the parent/guardian.
Study duration will be approximately 1 year. This includes Visit 1 (screening), Visit 2 (drug administration) and a follow up period of approximately 360 days (including 5 face-to-face visits, as well as telephone calls).
Approximately 1,500 infants will participate in the study at approximately 197 sites globally.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0416
Date of REC Opinion
22 Sep 2016
REC opinion
Further Information Favourable Opinion