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Thank you for your interest in this study.
RSV is the most common cause of lower respiratory illness in infants and young children. All children, including healthy term infants are at risk for severe RSV lower respiratory illness with primary infection during infancy. Palivizumab (Synagis) is the only approved agent for RSV prophylaxis, and its use is restricted to high-risk infants born before 29 weeks and infants with chronic illnesses. As a result, there is no approved RSV prophylaxis for the broader population of healthy preterm infants.
Based on advice from the US FDA, this initial pivotal study, funded by Medimmune, will help determine whether healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days gestational age, who would otherwise not be eligible to receive Synagis and who enter their first RSV season will benefit from receiving a single 50 mg intramuscular dose of MEDI8897 in reducing lower respiratory tract infections caused by RSV. Two clinical trials on MEDI8897 have been conducted thus far. One was in healthy adults and the other one is ongoing in healthy preterm infants 32 to 35 weeks gestation.
In a phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of MEDI8897, a monoclonal antibody with an extended half-life against RSV, healthy preterm infants 29 to 34 weeks entering their first RSV season will be randomized 2:1 to receive a single 50 mg intramuscular dose of MEDI8897 or placebo and followed for 1 year. We will compare the average number of RSV lower respiratory tract infections, changes in nasopharyngeal colonization and cost-effectiveness of each approach. Findings of this study will provide clinicians and parents dependable evidence concerning the overall safety and efficacy of MEDI8897 in reducing medically attended lower respiratory tract infections caused by RSV in healthy preterm infants 29 to 34 weeks entering their first RSV season, enabling evidence-based decisions regarding an important component of the children’s healthcare.
Below are links to information to enable full understanding of this research and to help with patient education and participation in this clinical study.
If you are not at one of the participating Pediatric PittNet sites and wish to refer a patient to the study, please:
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Children’s Hospital of Pittsburgh of UPMC
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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