Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
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研究单位：[1]Merck Sharp & Dohme LLC[2]Northwest Arkansas Pediatric Clinic ( Site 0050) Fayetteville, Arkansas, United States, 72703[3]Children's Clinic of Jonesboro, PA ( Site 0058) Jonesboro, Arkansas, United States, 72401[4]Long Beach Memorial Medical Center ( Site 0014) Long Beach, California, United States, 90806-1737[5]Madera Family Medical Group ( Site 0046) Madera, California, United States, 93637[6]Orange County Research Institute ( Site 0057) Ontario, California, United States, 91762[7]Children's Hospital Colorado ( Site 0066) Aurora, Colorado, United States, 80045[8]Optumcare Colorado Springs, LLC ( Site 0022) Colorado Springs, Colorado, United States, 80922[9]Children's National Hospital ( Site 0076) Washington, District of Columbia, United States, 20010[10]MedStar Georgetown Pediatrics ( Site 0047) Washington, District of Columbia, United States, 20016[11]Next Phase Research Alliance, LLC ( Site 0071) Homestead, Florida, United States, 33030[12]Acevedo Clinical Research Associates ( Site 0002) Miami, Florida, United States, 33142[13]Tekton Research ( Site 0080) Chamblee, Georgia, United States, 30341[14]Meridian Clinical Research, LLC ( Site 0083) Macon, Georgia, United States, 31210[15]Clinical Research Prime ( Site 0075) Idaho Falls, Idaho, United States, 83404[16]Saltzer Medical Group ( Site 0004) Nampa, Idaho, United States, 83686[17]Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061) Topeka, Kansas, United States, 66604[18]ACC Pediatric Research ( Site 0067) Haughton, Louisiana, United States, 71037[19]Midwest Children's Health Research Institute, LLC ( Site 0044) Lincoln, Nebraska, United States, 68504[20]Dartmouth-Hitchcock Medical Center ( Site 0031) Lebanon, New Hampshire, United States, 03756[21]Rutgers University-Pediatric Clinical Research Center ( Site 0055) New Brunswick, New Jersey, United States, 08901[22]Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093) Winston-Salem, North Carolina, United States, 27103[23]Senders Pediatrics ( Site 0062) Cleveland, Ohio, United States, 44121[24]Ohio Pediatric Research Association ( Site 0063) Dayton, Ohio, United States, 45414[25]CCP- Kid's Way ( Site 0017) Hermitage, Pennsylvania, United States, 16148[26]UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043) Pittsburgh, Pennsylvania, United States, 15213[27]Coastal Pediatric Research ( Site 0013) Charleston, South Carolina, United States, 29414[28]Tribe Clinical Research, LLC ( Site 0015) Greenville, South Carolina, United States, 29607[29]Holston Medical Group ( Site 0040) Kingsport, Tennessee, United States, 37660[30]Javara - Privia Medical Group North Texas - Frisco ( Site 0086) Frisco, Texas, United States, 75035[31]University of Texas Medical Branch at Galveston ( Site 0059) Galveston, Texas, United States, 77555[32]DM Clinical Research ( Site 0005) Houston, Texas, United States, 77065[33]FMC Science - Lampasas ( Site 0011) Lampasas, Texas, United States, 76550[34]DCOL Center for Clinical Research ( Site 0042) Longview, Texas, United States, 75605[35]University Health System- San Antonio ( Site 0048) San Antonio, Texas, United States, 78229[36]Private Practice - Dr. Etokhana ( Site 0089) San Antonio, Texas, United States, 78244[37]Road Runner Research, Ltd ( Site 0049) San Antonio, Texas, United States, 78249[38]Alliance for Multispecialty Research, LLC ( Site 0092) Kaysville, Utah, United States, 84037[39]Wee Care Pediatrics ( Site 0077) Layton, Utah, United States, 84041[40]Cottonwood Pediatrics ( Site 0032) Murray, Utah, United States, 84107[41]Wee Care Pediatrics-Roy ( Site 0053) Roy, Utah, United States, 84067[42]University of Utah School of Medicine ( Site 0006) Salt Lake City, Utah, United States, 84108[43]Copperview Medical Center ( Site 0078) South Jordan, Utah, United States, 84095[44]Wee Care Pediatrics ( Site 0065) Syracuse, Utah, United States, 84075[45]Pediatric Research of Charlottesville, LLC ( Site 0073) Charlottesville, Virginia, United States, 22902[46]MultiCare Rockwood Cheney Clinic ( Site 0068) Cheney, Washington, United States, 99004[47]Multicare Health System Institute for Research and Innovation ( Site 0025) Spokane, Washington, United States, 99202[48]Multicare Institute For Research And Innovation ( Site 0045) Tacoma, Washington, United States, 98405[49]Marshall University School of Medicine and Medical Center ( Site 0064) Huntington, West Virginia, United States, 25701[50]Marshfield Clinic ( Site 0054) Marshfield, Wisconsin, United States, 54449[51]Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001) Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426BOS[52]Clinica del Nino y la Madre ( Site 1005) Mar De La Plata, Buenos Aires, Argentina, B7600FYH[53]SANATORIO MATER DEI ( Site 1010) Buenos Aires, Argentina, C1425DND[54]Clinica Privada del Sol S.A ( Site 1013) Cordoba, Argentina, X5000IIH[55]Sanatorio del Salvador ( Site 1008) Cordoba, Argentina, X5004BCL[56]Universitair Ziekenhuis Antwerpen ( Site 2001) Edegem, Antwerpen, Belgium, 2650[57]Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003) Brussels, Bruxelles-Capitale, Region De, Belgium, 1000[58]Cabinet Médical Demeulemeester ( Site 2002) Gozée, Wallonne, Region, Belgium, 6534[59]AZ Delta ( Site 2004) Roeselare, West-Vlaanderen, Belgium, 8800[60]University of Calgary - Alberta Children Hospital ( Site 0504) Calgary, Alberta, Canada, T3B 6A8[61]BC Women s Hospital and Health Centre ( Site 0506) Vancouver, British Columbia, Canada, V6H 3N1[62]Canadian Center for Vaccinology ( Site 0503) Halifax, Nova Scotia, Canada, B3K 6R8[63]Hamilton Medical Research Group ( Site 0509) Hamilton, Ontario, Canada, L8M 1K7[64]CHU Sainte Justine ( Site 0502) Montreal, Quebec, Canada, H3T 1C5[65]McGill University Health Centre - Vaccine Study Centre ( Site 0500) Pierrefonds, Quebec, Canada, H9H 4Y6[66]CHU de Quebec Universite de Laval ( Site 0501) Quebec, Canada, G1E 7G9[67]Hospital La Florida ( Site 1104) Santiago, Region M. De Santiago, Chile, 8242238[68]Hospital Roberto del Rio ( Site 1106) Santiago, Region M. De Santiago, Chile, 8380418[69]Facultad Medicina Universidad de Chile ( Site 1105) Santiago, Region M. De Santiago, Chile, 8380453[70]Hospital Padre Hurtado ( Site 1101) Santiago, Region M. De Santiago, Chile, 8880465[71]Peking University Third Hospital ( Site 3339) Beijing, Beijing, China, 100091[72]The Children's Hospital of Chongqing Medical University ( Site 3333) Chongqing, Chongqing, China, 400065[73]Jiangjin District Central Hospital ( Site 3319) Chongqing, Chongqing, China, 402260[74]Xiamen Maternity and Child Health Care Hospital ( Site 3351) Xiamen, Fujian, China, 361003[75]Liuzhou People's Hospital ( Site 3364) Liuzhou, Guangxi, China, 545006[76]Hebei Petro China Central Hospital ( Site 3365) Langfang, Hebei, China, 065000[77]Fourth Hospital of Hebei Medical University ( Site 3366) Shijiazhuang, Hebei, China, 050035河北医科大学第四医院
研究目的：
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
