중증 호흡기 세포융합 바이러스(RSV) 질환(MK-1654-007)에 대한 위험이 증가된 영유아의 클레소로비맙(MK-1654) (SMART)
2026년 4월 17일 업데이트: Merck Sharp & Dohme LLC
중증 RSV 질병에 대한 위험이 증가된 영유아에서 MK-1654의 안전성, 효능 및 약동학을 평가하기 위한 3상, 다기관, 무작위, 부분 맹검, Palivizumab 제어 연구
이 연구는 부작용(AE)을 경험한 참가자의 비율로 평가할 때 palivizumab과 비교하여 clesrovimab의 안전성과 내약성을 평가하는 것을 목표로 합니다.
연구 개요
연구 유형
중재적
등록 (실제)
1003
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Attica
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Athens, Attica, 그리스, 115 27
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
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Athens, Attica, 그리스, 115 27
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
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Chaïdári, Attica, 그리스, 124 62
- ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
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Central Macedonia
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Thessaloniki, Central Macedonia, 그리스, 54642
- Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
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Gauteng
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Boksburg, Gauteng, 남아프리카, 1459
- Reimed ( Site 0706)
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Soweto, Gauteng, 남아프리카, 2013
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, 남아프리카, 4001
- King Edward VIII Hospital ( Site 0704)
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7500
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
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Cape Town, Western Cape, 남아프리카, 7500
- Panorama Medical Centre ( Site 0702)
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Cape Town, Western Cape, 남아프리카, 7700
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
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Cape Town, Western Cape, 남아프리카, 7824
- 2 Military Hospital ( Site 0708)
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Oslo, 노르웨이, 0450
- Oslo Universitetssykehus Ullevål ( Site 0551)
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-
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Auckland, 뉴질랜드, 2025
- Middlemore Clinical Trials ( Site 0526)
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Wellington Region
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Newtown, Wellington Region, 뉴질랜드, 6021
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
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-
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Taichung, 대만, 407
- Taichung Veterans General Hospital ( Site 0754)
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Taipei, 대만, 10449
- Mackay Memorial Hospital-Pediatrics ( Site 0753)
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Taipei, 대만, 10002
- National Taiwan University Hospital ( Site 0751)
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Taoyuan, 대만, 33305
- Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, 독일, 79106
- Universitaetsklinikum Freiburg ( Site 0365)
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Heidelberg, Baden-Wurttemberg, 독일, 69120
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
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Bavaria
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Munich, Bavaria, 독일, 80337
- Dr. von Haunersches Kinderspital ( Site 0358)
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Munich, Bavaria, 독일, 81545
- München Klinik Harlaching ( Site 0351)
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Lower Saxony
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Hanover, Lower Saxony, 독일, 30625
- Medizinische Hochschule Hannover ( Site 0364)
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North Rhine-Westphalia
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Oberhausen, North Rhine-Westphalia, 독일, 46145
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
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Saxony
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Dresden, Saxony, 독일, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
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Leipzig, Saxony, 독일, 04103
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, 독일, 23538
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
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-
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Kuala Lumpur, 말레이시아, 50300
- Hospital Tunku Azizah-Paediatric ( Site 0481)
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Kelantan
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Kota Bharu, Kelantan, 말레이시아, 15586
- Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
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Pulau Pinang
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George Town, Pulau Pinang, 말레이시아, 10450
- Hospital Pulau Pinang ( Site 0482)
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Sabah
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Kota Kinabalu, Sabah, 말레이시아, 88996
- Sabah Women and Children Hospital ( Site 0478)
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Sarawak
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Sibu, Sarawak, 말레이시아, 96000
- Hospital Sibu ( Site 0476)
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Durango, 멕시코, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
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Oaxaca City, 멕시코, 68000
- Oaxaca Site Management Organization ( Site 0504)
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San Luis Potosí City, 멕시코, 78209
- ONCOLOGICO POTOSINO, S.C. ( Site 0505)
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Guanajuato
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León, Guanajuato, 멕시코, 37000
- Morales Vargas Centro de Investigacion ( Site 0509)
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44650
- Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
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Mexico City
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Mexico City, Mexico City, 멕시코, 04530
- Instituto Nacional de Pediatria ( Site 0506)
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California
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Long Beach, California, 미국, 90806
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
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Orange, California, 미국, 92868
- Children's Hospital of Orange County ( Site 0047)
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Colorado
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Aurora, Colorado, 미국, 80045
- Children's Hospital Colorado ( Site 0011)
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- Children's National Medical Center ( Site 0020)
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Florida
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Orlando, Florida, 미국, 32827
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)
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Orlando, Florida, 미국, 32806
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
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Tampa, Florida, 미국, 33606
- University of South Florida-Department of Pediatrics ( Site 0045)
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Georgia
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Atlanta, Georgia, 미국, 30310
- Morehouse School Of Medicine ( Site 0049)
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Idaho
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Idaho Falls, Idaho, 미국, 83404
- Clinical Research Prime ( Site 0046)
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Kentucky
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Lexington, Kentucky, 미국, 40536
- University of Kentucky HealthCare - Turfland ( Site 0044)
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Our Lady of the Lake Children's Hospital ( Site 0031)
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New Orleans, Louisiana, 미국, 70112
- Tulane University School of Medicine ( Site 0010)
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Minnesota
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Minneapolis, Minnesota, 미국, 55454
- M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037)
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)
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New York
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Mineola, New York, 미국, 11501
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
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Rochester, New York, 미국, 14642
- University of Rochester Medical Center ( Site 0017)
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- The University of North Carolina at Chapel Hill ( Site 0035)
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Durham, North Carolina, 미국, 27710
- Duke University ( Site 0021)
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Ohio
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Dayton, Ohio, 미국, 45449
- Dayton Children's Hospital ( Site 0053)
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South Carolina
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Greenville, South Carolina, 미국, 29607
- Tribe Clinical Research, LLC ( Site 0002)
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Texas
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Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital ( Site 0025)
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Edinburg, Texas, 미국, 78539
- DHR Health Institute for Research and Development ( Site 0029)
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San Antonio, Texas, 미국, 78207
- Christus Children's-Clinical Research Center ( Site 0038)
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San Antonio, Texas, 미국, 78229
- University Hospital-Pediatrics ( Site 0019)
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San Antonio, Texas, 미국, 78249
- Road Runner Research, Ltd ( Site 0052)
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Utah
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Salt Lake City, Utah, 미국, 84113
- Intermountain - Primary Children's Hospital ( Site 0026)
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Washington
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Spokane, Washington, 미국, 99202
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
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Spokane, Washington, 미국, 99204
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
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Tacoma, Washington, 미국, 98405
- MultiCare Health System-Baker Center ( Site 0036)
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Madrid, 스페인, 28046
- Hospital Universitario La Paz ( Site 0726)
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Málaga, 스페인, 29015
- Grupo Pediatrico Uncibay ( Site 0734)
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Barcelona
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Badalona, Barcelona, 스페인, 08916
- Hospital Germans Trias i Pujol ( Site 0738)
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Esplugues de Llobregat, Barcelona, 스페인, 08950
- Hospital Sant Joan de Déu ( Site 0730)
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Sant Cugat del Vallès, Barcelona, 스페인, 08195
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
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La Coruna
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Santiago de Compostela, La Coruna, 스페인, 15706
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
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Madrid
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Boadilla del Monte, Madrid, 스페인, 28660
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
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Pozuelo de Alarcón, Madrid, 스페인, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, 스페인, 28041
- Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728)
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Principality of Asturias
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Oviedo, Principality of Asturias, 스페인, 33011
- Hospital Universitario Central de Asturias ( Site 0740)
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South West
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Singapore, South West, 싱가포르, 229899
- KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
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Liverpool, 영국, L12 2AP
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
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England
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London, England, 영국, E11 1NR
- Whipps Cross University Hospital ( Site 0846)
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London, England, 영국, SW17 0RE
- St. George's Hospital ( Site 0845)
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Glasgow City
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Glasgow, Glasgow City, 영국, G51 4TF
- Queen Elizabeth University Hospital ( Site 0842)
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Great Britain
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London, Great Britain, 영국, SE1 7EH
- Evelina London Children's Hospital ( Site 0829)
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Hampshire
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Southampton, Hampshire, 영국, SO16 0YD
- Southampton General Hospital ( Site 0826)
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London, City of
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London, London, City of, 영국, E1 1BB
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 9DU
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
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Parma, 이탈리아, 43126
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
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Lazio
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Rome, Lazio, 이탈리아, 00165
- Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
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Rome, Lazio, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
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Lombardy
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Milan, Lombardy, 이탈리아, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
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Milan, Lombardy, 이탈리아, 20154
- ASST Fatebenefratelli Sacco ( Site 0434)
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Veneto
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Padova, Veneto, 이탈리아, 35128
- Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
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-
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Shizuoka, 일본, 422-8527
- Shizuoka Saiseikai General Hospital ( Site 0456)
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Tokyo, 일본, 157-8535
- National Center for Child Health and Development ( Site 0455)
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Fukuoka
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Fukuoka, Fukuoka, 일본, 813-0017
- Fukuoka Children's Hospital ( Site 0452)
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Iizuka, Fukuoka, 일본, 820-8505
- Iizuka Hospital ( Site 0457)
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Kitakyushu-shi, Fukuoka, 일본, 806-8501
- Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
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Gunma
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Maebashi, Gunma, 일본, 371-0811
- Maebashi Red Cross Hospital ( Site 0451)
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Ibaraki
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Mito, Ibaraki, 일본, 311-4145
- Ibaraki Children's Hospital ( Site 0458)
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Tokyo
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Itabashiku, Tokyo, 일본, 173-8610
- Nihon University Itabashi Hospital ( Site 0453)
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, 체코, 708 52
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
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Praha 4
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Prague, Praha 4, 체코, 14700
- Institute for the Care of Mother and Child ( Site 0251)
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Region M. de Santiago
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Santiago, Region M. de Santiago, 칠레, 8320325
- Clínica Alemana de Santiago-Neonatology department ( Site 0207)
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Santiago, Region M. de Santiago, 칠레, 8380418
- Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
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Santiago, Region M. de Santiago, 칠레, 8880465
- Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
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Alberta
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Calgary, Alberta, 캐나다, T3B 6A8
- Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3K 6R8
- Canadian Center for Vaccinology ( Site 0179)
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Quebec
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Montreal, Quebec, 캐나다, H3T 1C5
- CHU Sainte-Justine ( Site 0178)
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-
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Antioquia
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Medellín, Antioquia, 콜롬비아, 050010
- Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
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Medellín, Antioquia, 콜롬비아, 50036
- Clínica Universitaria Bolivariana ( Site 0227)
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Atlántico
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Barranquilla, Atlántico, 콜롬비아, 08001
- Ciensalud Ips S A S ( Site 0235)
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Bogota D.C.
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Bogotá, Bogota D.C., 콜롬비아, 111411
- Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, 콜롬비아, 760042
- Clínica Imbanaco S.A.S ( Site 0229)
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-
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Bangkok
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Bangkok, Bangkok, 태국, 10330
- Chulalongkorn University-Pediatrics ( Site 0777)
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Bangkok, Bangkok, 태국, 10700
- Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, 태국, 90110
- Songklanagarind hospital-Department of Pediatrics ( Site 0776)
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-
-
-
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Ankara, 터키 (Türkiye), 06100
- Ankara University Hospital Cebeci ( Site 0801)
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Ankara, 터키 (Türkiye), 06560
- Gazi Universitesi ( Site 0806)
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Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)
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Kayseri, 터키 (Türkiye), 38039
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)
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Adana
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Sarçam, Adana, 터키 (Türkiye), 01030
- cukurova universty ( Site 0805)
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-
-
-
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Lima, 페루, 15001
- HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
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Lima
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Jesús María, Lima, 페루, 15072
- Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
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-
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San Juan, 푸에르토 리코, 00935
- UPR Medical Sciences Campus-Pediatrics ( Site 0626)
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-
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Aquitaine
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Bordeaux, Aquitaine, 프랑스, 33076
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
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Calvados
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Caen, Calvados, 프랑스, 14033
- Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330)
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Yvelines
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Le Chesnay, Yvelines, 프랑스, 78157
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
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-
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Keski-Pohjanmaa
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Kokkola, Keski-Pohjanmaa, 핀란드, 67100
- FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
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North Ostrobothnia
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Oulu, North Ostrobothnia, 핀란드, 90220
- FVR, Oulun rokotetutkimusklinikka ( Site 0303)
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Pirkanmaa
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Tampere, Pirkanmaa, 핀란드, 33100
- FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
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South Ostrobothnia
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Seinäjoki, South Ostrobothnia, 핀란드, 60100
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
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Southwest Finland
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Turku, Southwest Finland, 핀란드, 20520
- FVR, Turun rokotetutkimusklinikka ( Site 0302)
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Uusimaa
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Helsinki, Uusimaa, 핀란드, 00290
- MeVac - Meilahti Vaccine Research Center ( Site 0306)
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-
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Budapest, 헝가리, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
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Budapest, 헝가리, 1082
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
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Budapest, 헝가리, 1096
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
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Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)
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Borsod-Abauj Zemplen county
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Miskolc, Borsod-Abauj Zemplen county, 헝가리, 3526
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388)
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Bács-Kiskun county
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Baja, Bács-Kiskun county, 헝가리
- Bajai Szent Rókus Kórház ( Site 0386)
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Kecskemét, Bács-Kiskun county, 헝가리, 6000
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, 헝가리, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
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Queensland
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Brisbane, Queensland, 호주, 4101
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)
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Western Australia
-
Nedlands, Western Australia, 호주, 6009
- Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
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-
-
-
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Shatin, 홍콩
- Prince of Wales Hospital ( Site 0926)
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Tuenmen, 홍콩, 999077
- Tuen Mun Hospital ( Site 0927)
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참여기준
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아니
설명
포함 기준:
- 중증 RSV 감염 위험이 높은 참가자는 국가 또는 지역 지침 또는 전문 사회 권장 사항에 따라 palivizumab을 받을 것을 권장합니다.
- 후속 조치 기간을 완료하는 데 사용할 수 있습니다.
제외 기준:
- 등록 시 기계적 환기가 필요합니다.
- 수명이 있습니다
- 간 또는 신장 기능 장애 또는 만성 발작 장애가 있는 것으로 알려져 있습니다.
- 무작위 배정 후 7일 이내에 퇴원이 예상되지 않는 한 무작위 배정 시점에 입원한 경우.
- 중증 면역결핍이 있거나 중증 면역저하 상태입니다.
- clesrovimab 또는 palivizumab의 성분에 대해 알려진 과민증이 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 클레소로비맙
참가자는 클레스로비맙과 위약을 근육주사(IM)로 받게 됩니다.
|
IM 주입
다른 이름들:
IM 주입
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활성 비교기: 팔리비주맙
참가자는 IM 주사를 받게 됩니다.
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IM 주입
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
기간: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited injection-site AEs included erythema, pain, and swelling.
The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
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Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
|
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Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1
기간: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F.
The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.
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Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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Number of Participants With Solicited Systemic AEs in RSV Season 1
기간: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited systemic AEs included decreased appetite, irritability, and somnolence.
The number of participants with solicited systemic AEs in RSV Season 1 is reported.
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Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1
기간: Up to 42 days in RSV Season 1
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.
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Up to 42 days in RSV Season 1
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Number of Participants With Rash AESI in RSV Season 1
기간: Up to 42 days in RSV Season 1
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Rash AESI included urticaria and drug eruption.
The number of participants with rash AESI in RSV Season 1 is reported.
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Up to 42 days in RSV Season 1
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Number of Participants With Nonserious AEs in RSV Season 1
기간: Up to 42 days in RSV Season 1
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with nonserious AEs in RSV Season 1 is reported.
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Up to 42 days in RSV Season 1
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Number of Participants With Serious AEs (SAEs) Through the Duration of Participation in RSV Season 1
기간: Up to 365 days in RSV Season 1
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An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
The number of participants with SAEs in RSV Season 1 is reported.
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Up to 365 days in RSV Season 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
기간: Up to 150 days in RSV Season 1
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Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal (NP) sample.
The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1.
For each participant, only the first occurrence of the case is counted for the analysis.
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Up to 150 days in RSV Season 1
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Number of Cases of RSV-associated Hospitalization in RSV Season 1
기간: Up to 150 days in RSV Season 1
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RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR NP sample.
The number of cases of RSV-associated hospitalization in RSV Season 1 is reported.
For each participant, only the first occurrence of the case is counted for the analysis.
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Up to 150 days in RSV Season 1
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Number of Participants With Solicited Injection-site AEs in RSV Season 2
기간: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited injection-site AEs included erythema, pain, and swelling.
The number of participants with solicited injection-site AEs in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2
기간: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F.
The number of participants with solicited daily body temperature of fever in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 2
기간: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited systemic AEs included decreased appetite, irritability, and somnolence.
The number of participants with solicited systemic AEs in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2
기간: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 is reported.
|
Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With Rash AESI in RSV Season 2
기간: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Rash AESI included urticaria and drug eruption.
The number of participants with rash AESI in RSV Season 2 is reported.
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Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With Nonserious AEs in RSV Season 2
기간: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with nonserious AEs in RSV Season 2 is reported.
|
Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With SAEs in RSV Season 2
기간: Up 180 days postdose in RSV Season 2 (Up to ~575 days)
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An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
The number of participants with SAEs in RSV Season 2 is reported.
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Up 180 days postdose in RSV Season 2 (Up to ~575 days)
|
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Concentration of Clesrovimab in RSV Season 1
기간: At Day 7, Day 150, and Day 240 in RSV Season 1
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Blood samples were collected to determine the serum concentration of clesrovimab at Days 7, 150, and 240 in RSV Season 1.
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At Day 7, Day 150, and Day 240 in RSV Season 1
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Concentration of Clesrovimab in RSV Season 2
기간: At Day 7 and Day 150 postdose in RSV Season 2
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Blood samples were collected to determine the serum concentration of clesrovimab at Days 7 and 150 in RSV Season 2. RSV Season 2 began 246-393 days after RSV Season 1 dose 1.
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At Day 7 and Day 150 postdose in RSV Season 2
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Zar HJ, Bont LJ, Manzoni P, Munoz FM, Ramilo O, Chen PY, Novoa JM, Ordonez GA, Tsolia M, Tapiero B, Acuna-Avila MI, Castellanos JM, Meyer M, Morioka I, Chen Z, Railkar RA, Zang X, Maas BM, Likos A, Lee AW, Castagnini LA, Sinha A; SMART (MK-1654-007) Study Group. Clesrovimab in Infants and Children at Increased Risk for Severe RSV Disease. N Engl J Med. 2025 Oct 2;393(13):1343-1345. doi: 10.1056/NEJMc2506107. Epub 2025 Sep 17. No abstract available.
- Sinha A, Railkar RA, Castagnini L, Guerra A, Likos A, Lutkiewicz J, Maas BM, Zang X, Roadcap BA, Choi Y, Nahhas GJ, Arriola CS, Bont L, Manzoni P, Ramilo O, Munoz FM, Finelli L, Lee AW. Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials. Contemp Clin Trials. 2025 Oct;157:107995. doi: 10.1016/j.cct.2025.107995. Epub 2025 Jun 30.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 11월 30일
기본 완료 (실제)
2025년 4월 28일
연구 완료 (실제)
2025년 8월 1일
연구 등록 날짜
최초 제출
2021년 6월 22일
QC 기준을 충족하는 최초 제출
2021년 6월 22일
처음 게시됨 (실제)
2021년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 17일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1654-007
- MK-1654-007 (기타 식별자: MSD)
- jRCT2031210664 (레지스트리 식별자: jRCT)
- 2020-005996-11 (EudraCT 번호)
- U1111-1278-0093 (레지스트리 식별자: UTN)
- 2022-500752-39-00 (레지스트리 식별자: EU CT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .