|Title||R2222-RSV-1332;A Phase 3, Randomized, Double-blind, Placebo controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants|
|Summary||This study is for preterm, otherwise healthy infants who may be at risk for respiratory syncytial virus (RSV). RSV is a virus that is present in communities mostly from late fall to early spring. In the first year of life, about half of all infants become infected with RSV. By 3 years of age, almost all children have been infected with this virus. RSV infection usually causes mild illness like a cold, but it may cause serious illness like bronchiolitis (lung infection) leading to medical attention including hospitalizations. The investigational product called REGN2222 is being studied for prevention of lower respiratory tract (lung) infection due to RSV infection.|
|Description||This study involves research for the purpose of seeing how effective REGN2222 is at reducing medical visits for RSV infection when it is administered intramuscularly (IM), by inserting a needle into the muscle. This is exactly how vaccines are given to your infant. The study will take place with infants born at no more than 35 weeks gestation (up to 35 weeks 6 days) and not older than 6 months of age at the time of enrollment. REGN2222 is being studied for prevention of lower respiratory tract (lung) infection due to RSV infection. REGN2222 is a human antibody that binds the RSV virus and stops the virus from infecting the cells in the airways and lungs.|
Your infant may qualify for this study. Study participation is approximately 5 ½ months. If you enroll your infant in this study, they will receive 2 doses of REGN2222 and will have their blood drawn during the duration of the study.
|Inclusion/Notes||Infants must be less than 6 months of age at time of study enrollment. They must have history of prematurity – 29 to less than 35 weeks 6 days gestational age.|
|Principal Name||Dr. Leonard R. Krilov, MD|
|Contact Name||Ann Mock, RN CCRC|