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) 

Status: Closed to Recruitment

Population: Paediatric 

Disease group: RSV 

Funder: MedImmune 

Sponsor: MedImmune 

Principal Investigator: Dr Eva Galiza 

Study Aims

In this study, MEDI8897 is being evaluated to determine how effective it is at preventing serious Respiratory Syncytial Virus (RSV) disease in late preterm and term infants in their first year of life.  

MedImmune, a member of the AstraZeneca group, is doing this research to find out if the experimental study drug called MEDI8897 (an antibody product, similar to a vaccine) will work and be safe for the prevention of RSV lower respiratory tract infection in infants and young children. RSV is a virus that is present in communities mostly from autumn to early spring. Infection with RSV is common in all children. In the first year of life, about half of all infants become infected with RSV. By 2 years of age, almost all children have been infected with this virus. RSV typically causes a cold-like illness in older children and adults but can cause serious disease in infants and young children. 

There are currently no medicines to prevent RSV in healthy infants who are greater than 35 weeks gestation at birth, and there are no medicines to treat children with RSV infection. Palivizumab (Synagis®) is the only FDA approved medicine for the prevention of serious illness caused by RSV, and its use is limited to high-risk children: preterm infants less than or equal to 35 weeks gestational age, children with chronic lung disease of prematurity (also known as bronchopulmonary dysplasia) and children with congenital heart disease  

What does participating in the study involve? 

If you decide you would like your child to take part, your study doctor will first look at your child’s medical records, ask you questions about your child’s health and do tests to see if this research study is right for your child. If it is determined that this research study is right for your child, your child will be given the study drug, a single dose of MEDI8897 or placebo. Your child has a 2 in 3 chance of being given MEDI8897 as compared to placebo. The study drug your child gets is chosen at random by a computer. Neither you nor your study doctor will know if your child received MEDI8897 or placebo until the study is completed. 

If your child takes part in the research, you will need to bring your child to the study site for at least 6 visits over 17 months and also be available for a number of phone calls. At any time during the study, if you take your child to any health care provider (doctor’s (GP) office or clinic, Accident & Emergency (A&E) department, or hospital) for a respiratory illness, you will also need to bring your child to the study site within 2 days or as soon as possible for a follow up visit. The visits will last at least 1 hour. It may be possible to carry out some of these visits, excepting dosing visits, at your home to make it easier for you. The study doctor and their team will discuss this with you, if required.