Last updated on September 2018

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.


Brief description of study

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age and entering their first RSV season.

Detailed Study Description

This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days gestational age (GA) who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Subjects will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.

Clinical Study Identifier: NCT02878330

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Birmingham, AL United States

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Huntsville, AL United States

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Anaheim, CA United States

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Downey, CA United States

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Los Angeles, CA United States

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Paramount, CA United States

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West Covina, CA United States

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Aurora, CO United States

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Colorado Springs, CO United States

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Gainesville, FL United States

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Orlando, FL United States

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South Miami, FL United States

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Atlanta, GA United States

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Augusta, GA United States

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Chicago, IL United States

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Oak Lawn, IL United States

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Park Ridge, IL United States

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Topeka, KS United States

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Woburn, MA United States

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Detroit, MI United States

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Duluth, MN United States

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Jackson, MS United States

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Columbia, MO United States

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Lincoln, NE United States

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Omaha, NE United States

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Liverpool, NY United States

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Mineola, NY United States

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New Hyde Park, NY United States

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Syracuse, NY United States

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Boone, NC United States

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Raleigh, NC United States

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Cincinnati, OH United States

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Columbus, OH United States

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Dayton, OH United States

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Toledo, OH United States

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Gresham, OR United States

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Erie, PA United States

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Pittsburgh, PA United States

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Barnwell, SC United States

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North Charleston, SC United States

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Kingsport, TN United States

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Memphis, TN United States

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Tullahoma, TN United States

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Baytown, TX United States

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Edinburg, TX United States

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Fort Worth, TX United States

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Galveston, TX United States

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Longview, TX United States

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San Antonio, TX United States

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Layton, UT United States

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Orem, UT United States

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Roy, UT United States

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Seattle, WA United States

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Huntington, WV United States

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Morgantown, WV United States

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Bahía Blanca, Argentina

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Ciudad Autónoma de Buenos Aire, Argentina

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Guaymallen Mendoza, Argentina

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San Miguel de Tucuman, Argentina

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Clayton, Australia

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Hobart, Australia

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Melbourne, Australia

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Subiaco, Australia

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Westmead, Australia

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Gent, Belgium

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Mons, Belgium

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Belo Horizonte, Brazil

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Botucatu, Brazil

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Campinas, Brazil

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Canoas, Brazil

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Curitiba, Brazil

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Juiz de Fora, Brazil

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Passo Fundo, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Sorocaba, Brazil

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Ruse, Bulgaria

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Sofia, Bulgaria

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Newmarket, ON Canada

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Santiago, Chile

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Valdivia, Chile

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Viña del Mar, Chile

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Havlickuv Brod, Czechia

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Praha 4, Czechia

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Tallinn, Estonia

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Tartu, Estonia

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Oulu, Finland

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Tampere, Finland

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Turku, Finland

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Bordeaux, France

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Brest, France

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Caen Cedex, France

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Dijon, France

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Grenoble Cedex, France

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Le Mans, France

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MARSEILLE Cedex 20, France

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Tours CEDEX 9, France

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Budapest, Hungary

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Gyula, Hungary

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Kecskemét, Hungary

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Miskolc, Hungary

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Szeged, Hungary

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Szekszárd, Hungary

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Veszprém, Hungary

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Genova, Italy

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Valencia, Spain

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Stockholm, Sweden

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Chernivtsi, Ukraine

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