RSV Prevention Study
Study title: 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
Age range: Children less than 1 year of age
Study criteria: Healthy premature babies born between 29 weeks to 34 weeks.
Contact email: firstname.lastname@example.org
Contact Phone number: 404-727-4044
The purpose of this study is to see how well MEDI8897 (study drug) protects premature infants from getting Respiratory Syncytial Virus (RSV). RSV is a common virus that can cause children to have serious breathing problems. Children born prematurely are more likely to get sick with this virus. There is no treatment for RSV.
There is a medicine called palivizumab (Synagis®) that approved by the US Food and Drug Administration (FDA) for prevention of RSV illness in premature infants. In 2014, American Academy of Pediatrics (AAP) issued guidelines that limit the use of Synagis® to infants who are born before 29 weeks gestational age. Synagis® is not given to otherwise healthy infants born at or after 29 weeks gestation.
MEDI8897 works in the same way as Synagis but can be given to healthy premature babies who are born after 29 weeks.
Who Can Participate?
Healthy premature babies who are less than one year old.
What is involved?
The study has 6-7 clinic visits at Emory Children’s Center, over 1 year. Each visit will last between 1-2 hours each. There will be 4 blood draws over 1 year. Children will receive a single dose of either MEDI8897 or placebo at the first visit.
What are the benefits?
Your child may not receive any benefits from being in this study. If your child receives MEDI8897 it is possible it may prevent RSV infection. It is not guaranteed your child will receive MEDI8897 or that MEDI8897 will prevent an RSV infection. The information learned from this study may help prevent other children from getting RSV.
This study is free. To say thank you, families will be compensated for their time and participation.