Breakthrough shot tested to shield babies from dangerous RSV
NCT ID NCT04767373
Summary
This study tested a single shot called clesrovimab (MK-1654) to see if it could prevent serious lower respiratory infections caused by RSV in healthy babies. Over 3,600 infants, including those born prematurely, received either the shot or a placebo. The main goal was to see if the shot safely reduced the number of babies needing medical care for RSV-related breathing problems in the 150 days after receiving it.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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A.O. Policlinico Consorziale di Bari ( Site 2309)
Bari, 70124, Italy
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A.O.Universitaria Meyer ( Site 2306)
Florence, Tuscany, 50139, Italy
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ACC Pediatric Research ( Site 0067)
Haughton, Louisiana, 71037, United States
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AZ Delta ( Site 2004)
Roeselare, West-Vlaanderen, 8800, Belgium
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Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)
Aalborg, North Denmark, 9000, Denmark
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Acevedo Clinical Research Associates ( Site 0002)
Miami, Florida, 33142, United States
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Ageo Central General Hospital ( Site 3051)
Ageo, Saitama, 362-8588, Japan
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Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)
Liverpool, L12 2AP, United Kingdom
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Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
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Alliance for Multispecialty Research, LLC ( Site 0092)
Kaysville, Utah, 84037, United States
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Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)
Ankara, 06590, Turkey (Türkiye)
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Asociacion Civil Selva Amazonica ( Site 1255)
Iquitos, Loreto, 16001, Peru
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BC Women s Hospital and Health Centre ( Site 0506)
Vancouver, British Columbia, V6H 3N1, Canada
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Baragwanath Hospital ( Site 2501)
Johannesburg, Gauteng, 2013, South Africa
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CAIMED Investigación en Salud S.A de C.V ( Site 1209)
Mexico City, Mexico City, 06760, Mexico
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CCP- Kid's Way ( Site 0017)
Hermitage, Pennsylvania, 16148, United States
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CHU Caen ( Site 2212)
Caen, Calvados, 14033, France
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CHU Sainte Justine ( Site 0502)
Montreal, Quebec, H3T 1C5, Canada
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CHU de Quebec Universite de Laval ( Site 0501)
Québec, Quebec, G1E 7G9, Canada
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Cabinet Médical Demeulemeester ( Site 2002)
Gozée, Wallonne, Region, 6534, Belgium
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Canadian Center for Vaccinology ( Site 0503)
Halifax, Nova Scotia, B3K 6R8, Canada
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Centenario Hospital Miguel Hidalgo ( Site 1204)
Aguascalientes, 20259, Mexico
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Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)
Brussels, Bruxelles-Capitale, Region de, 1000, Belgium
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Centre Hospitalier de Versailles ( Site 2206)
Le Chesnay, Yvelines, 78150, France
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Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)
Chía, Cundinamarca, 250001, Colombia
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Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)
Cali, Valle del Cauca Department, 760001, Colombia
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Centrum Medyczne PROMED ( Site 2432)
Krakow, Lesser Poland Voivodeship, 31-411, Poland
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Centrum Medyczne Pratia Warszawa ( Site 2438)
Warsaw, Masovian Voivodeship, 01-868, Poland
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Chaim Sheba Medical Center ( Site 2353)
Ramat Gan, 5265601, Israel
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Changde First People's Hospital ( Site 3311)
Changde, Hunan, 415000, China
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Chengdu Women and Children Center Hospital ( Site 3332)
Chengdu, Sichuan, 610091, China
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Children's Clinic of Jonesboro, PA ( Site 0058)
Jonesboro, Arkansas, 72401, United States
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Children's Hospital Colorado ( Site 0066)
Aurora, Colorado, 80045, United States
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Children's Hospital of Fudan University ( Site 3361)
Shanghai, Shanghai Municipality, 201102, China
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Children's National Hospital ( Site 0076)
Washington D.C., District of Columbia, 20010, United States
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Chulalongkorn University-Pediatrics ( Site 3252)
Bangkok, Bangkok, 10330, Thailand
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Chungang University Hospital ( Site 3211)
Dongjak-gu, Seoul, 06973, South Korea
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Clinica Peruano Americana S.A. ( Site 1253)
Trujillo, La Libertad, 13011, Peru
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Clinica Privada del Sol S.A ( Site 1013)
Córdoba, X5000IIH, Argentina
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Clinica de la Costa S.A.S. ( Site 1152)
Barranquilla, Atlántico, 080020, Colombia
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Clinica del Nino y la Madre ( Site 1005)
Mar de La Plata, Buenos Aires, B7600FYH, Argentina
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Clinical Research Prime ( Site 0075)
Idaho Falls, Idaho, 83404, United States
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Cliniques Universitaires Saint-Luc ( Site 2005)
Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
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Coastal Pediatric Research ( Site 0013)
Charleston, South Carolina, 29414, United States
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Copperview Medical Center ( Site 0078)
South Jordan, Utah, 84095, United States
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Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)
Topeka, Kansas, 66604, United States
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Cottonwood Pediatrics ( Site 0032)
Murray, Utah, 84107, United States
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Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)
Adana, 01330, Turkey (Türkiye)
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DCOL Center for Clinical Research ( Site 0042)
Longview, Texas, 75605, United States
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DM Clinical Research ( Site 0005)
Houston, Texas, 77065, United States
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Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33
Dalian, Liaoning, 116012, China
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Dartmouth-Hitchcock Medical Center ( Site 0031)
Lebanon, New Hampshire, 03756, United States
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Ege University Medical Faculty ( Site 2553)
Izmir, 35100, Turkey (Türkiye)
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Empilweni Services and Research Unit ( Site 2504)
Johannesburg, Gauteng, 2093, South Africa
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Enhancing Care Foundation-DICRS ( Site 2506)
Durban, KwaZulu-Natal, 4013, South Africa
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Erciyes University Medical Faculty-pediatric infection ( Site 2554)
Kayseri, 38039, Turkey (Türkiye)
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FMC Science - Lampasas ( Site 0011)
Lampasas, Texas, 76550, United States
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FVR, Espoon rokotetutkimusklinikka ( Site 2152)
Espoo, Uusimaa, 02230, Finland
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FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)
Helsinki, Uusimaa, 00100, Finland
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FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)
Helsinki, Uusimaa, 00930, Finland
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FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)
Jarvenpaa, Uusimaa, 04400, Finland
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FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)
Kokkola, Keski-Pohjanmaa, 67100, Finland
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FVR, Oulun rokotetutkimusklinikka ( Site 2158)
Oulu, North Ostrobothnia, 90220, Finland
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FVR, Porin rokotetutkimusklinikka ( Site 2156)
Pori, Satakunta, 28100, Finland
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FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)
Seinäjoki, South Ostrobothnia, 60100, Finland
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FVR, Turun rokotetutkimusklinikka ( Site 2151)
Turku, Southwest Finland, 20520, Finland
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Facultad Medicina Universidad de Chile ( Site 1105)
Santiago, Region M. de Santiago, 8380453, Chile
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Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)
Quezon City, National Capital Region, 1118, Philippines
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)
Milan, 20122, Italy
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Fourth Hospital of Hebei Medical University ( Site 3366)
Shijiazhuang, Hebei, 050035, China
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Fukui Aiiku Hospital ( Site 3056)
Fukui, 910-0833, Japan
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Fukui-ken Saiseikai Hospital ( Site 3064)
Fukui, 918-8503, Japan
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Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)
Ankara, 06560, Turkey (Türkiye)
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Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)
Lodz, Łódź Voivodeship, 91-347, Poland
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Groupe Hospitalier Pellegrin ( Site 2218)
Bordeaux, Gironde, 33000, France
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Guangdong Maternity and Child Health Care Hospital ( Site 3340)
Guangzhou, Guangdong, 511400, China
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Guangdong Provincial People's Hospital ( Site 3341)
Guangzhou, Guangdong, 510080, China
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Hallym University Sacred Heart Hospital ( Site 3207)
Anyang, Kyonggi-do, 14068, South Korea
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Hamilton Medical Research Group ( Site 0509)
Hamilton, Ontario, L8M 1K7, Canada
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Hebei Petro China Central Hospital ( Site 3365)
Langfang, Hebei, 065000, China
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Holston Medical Group ( Site 0040)
Kingsport, Tennessee, 37660, United States
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Hospital Angeles Lomas ( Site 1207)
Huixquilucan, 52763, Mexico
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Hospital La Florida ( Site 1104)
Santiago, Region M. de Santiago, 8242238, Chile
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Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426BOS, Argentina
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Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)
Lima, 15001, Peru
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Hospital Padre Hurtado ( Site 1101)
Santiago, Region M. de Santiago, 8880465, Chile
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Hospital Pulau Pinang ( Site 3104)
George Town, Pulau Pinang, 10990, Malaysia
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Hospital Raja Perempuan Zainab II ( Site 3106)
Kota Bharu, Kelantan, 15586, Malaysia
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Hospital Roberto del Rio ( Site 1106)
Santiago, Region M. de Santiago, 8380418, Chile
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Hospital Seberang Jaya ( Site 3107)
Seberang Jaya, Pulau Pinang, 13700, Malaysia
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Hospital Seri Manjung ( Site 3103)
Seri Manjung, Perak, 32040, Malaysia
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Hospital Sibu ( Site 3101)
Sibu, Sarawak, 96000, Malaysia
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Hospital Taiping ( Site 3108)
Taiping, Perak, 34000, Malaysia
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Hunan Provincial People's Hospital ( Site 3355)
Changsha, Hunan, 410005, China
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Hunan Shaoyang No.1 People's Hospital ( Site 3345)
Shaoyang, Hunan, 422000, China
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IN VIVO ( Site 2401)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland
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Instituto Nacional de Pediatria ( Site 1202)
Mexico City, 04530, Mexico
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Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)
Lima, LIMA 36, Peru
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Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)
Poznan, Greater Poland Voivodeship, 60-129, Poland
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JOHAS Yokohama Rosai Hospital ( Site 3058)
Yokohama, Kanagawa, 222-0036, Japan
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Javara - Privia Medical Group North Texas - Frisco ( Site 0086)
Frisco, Texas, 75035, United States
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Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)
Winston-Salem, North Carolina, 27103, United States
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Jeonbuk National University Hospital ( Site 3210)
Jeonju, Jeonrabugdo, 54907, South Korea
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Jiangjin District Central Hospital ( Site 3319)
Chongqing, Chongqing Municipality, 402260, China
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Jiangxi Pingxiang People's Hospital ( Site 3312)
Pingxiang, Jiangxi, 337000, China
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Jiangxi Provincial Children's Hospital ( Site 3313)
Nanchang, Jiangxi, 330006, China
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Korea University Ansan Hospital ( Site 3212)
Ansan-si, Kyonggi-do, 15355, South Korea
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Linfen Central Hospital ( Site 3368)
Linfen, Shanxi, 041000, China
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Linfen People's Hospital ( Site 3363)
Linfen, Shanxi, 041081, China
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Liuzhou People's Hospital ( Site 3364)
Liuchow, Guangxi, 545006, China
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Long Beach Memorial Medical Center ( Site 0014)
Long Beach, California, 90806, United States
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MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)
Cape Town, Western Cape, 7700, South Africa
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MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)
Mazowieckie, Masovian Voivodeship, 02-972, Poland
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Madera Family Medical Group ( Site 0046)
Madera, California, 93637, United States
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Maebashi Red Cross Hospital ( Site 3057)
Maebashi, Gunma, 371-0811, Japan
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Maharaj Nakorn Chiang Mai Hospital ( Site 3254)
Chiang Mai, 50200, Thailand
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Marshall University School of Medicine and Medical Center ( Site 0064)
Huntington, West Virginia, 25701, United States
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Marshfield Clinic ( Site 0054)
Marshfield, Wisconsin, 54449, United States
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McGill University Health Centre - Vaccine Study Centre ( Site 0500)
Pierrefonds, Quebec, H9H 4Y6, Canada
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MedStar Georgetown Pediatrics ( Site 0047)
Washington D.C., District of Columbia, 20016, United States
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Meridian Clinical Research, LLC ( Site 0082)
Hastings, Nebraska, 68901, United States
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Meridian Clinical Research, LLC ( Site 0083)
Macon, Georgia, 31210, United States
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Midwest Children's Health Research Institute, LLC ( Site 0044)
Lincoln, Nebraska, 68504, United States
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MultiCare Rockwood Cheney Clinic ( Site 0068)
Cheney, Washington, 99004, United States
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Multicare Health System Institute for Research and Innovation ( Site 0025)
Spokane, Washington, 99202, United States
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Multicare Institute For Research And Innovation ( Site 0045)
Tacoma, Washington, 98405, United States
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NZOZ Salmed ( Site 2433)
Łęczna, Lublin Voivodeship, 21-010, Poland
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National Hospital Organization Beppu Medical Center ( Site 3063)
Beppu, Oita Prefecture, Japan
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Next Phase Research Alliance, LLC ( Site 0071)
Homestead, Florida, 33030, United States
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Ningbo Women and Children's Hospital ( Site 3314)
Ningbo, Zhejiang, 315012, China
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Northwest Arkansas Pediatric Clinic ( Site 0050)
Fayetteville, Arkansas, 72703, United States
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Odense University Hospital ( Site 2107)
Odense, Region Syddanmark, 5000, Denmark
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Ohio Pediatric Research Association ( Site 0063)
Dayton, Ohio, 45414, United States
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Optumcare Colorado Springs, LLC ( Site 0022)
Colorado Springs, Colorado, 80922, United States
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Orange County Research Institute ( Site 0057)
Ontario, California, 91762, United States
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Oxford University Hospital NHS Foundation Trust ( Site 2604)
Oxford, Oxfordshire, OX3 9DU, United Kingdom
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Pediatric Research of Charlottesville, LLC ( Site 0073)
Charlottesville, Virginia, 22902, United States
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Peking University Third Hospital ( Site 3339)
Beijing, Beijing Municipality, 100091, China
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Philippine Children s Medical Center ( Site 3154)
Quezon City, National Capital Region, 1100, Philippines
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Policlinico Universitario Gemelli ( Site 2301)
Rome, Roma, 00168, Italy
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Prince of Songkla University Faculty of Medicine ( Site 3255)
Hat Yai, Changwat Songkhla, 90110, Thailand
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Private Practice - Dr. Etokhana ( Site 0089)
San Antonio, Texas, 78244, United States
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Pusan National University Hospital ( Site 3206)
Busan, Pusan-Kwangyokshi, 49241, South Korea
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Rambam Medical Center ( Site 2352)
Haifa, 3525408, Israel
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Regionshospitalet Herning ( Site 2105)
Herning, Central Jutland, 7400, Denmark
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Regionshospitalet Nordjylland ( Site 2102)
Hjørring, North Denmark, 9800, Denmark
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Renmin Hospital of Wuhan University ( Site 3316)
Wuhan, Hubei, 430060, China
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Road Runner Research, Ltd ( Site 0049)
San Antonio, Texas, 78249, United States
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Royal Maternity Hospital ( Site 2602)
Belfast, Northern Ireland, BT12 6BB, United Kingdom
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Rutgers University-Pediatric Clinical Research Center ( Site 0055)
New Brunswick, New Jersey, 08901, United States
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SANATORIO DEL SALVADOR-Pediatria ( Site 1008)
Córdoba, Córdoba Province, 5004, Argentina
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SANATORIO MATER DEI ( Site 1010)
Buenos Aires, C1425DND, Argentina
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Sabah Womens & Childrens Hospital ( Site 3102)
Kota Kinabalu, Sabah, 88996, Malaysia
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Saitama City Hospital ( Site 3055)
Saitama, 336-8522, Japan
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Saltzer Medical Group ( Site 0004)
Nampa, Idaho, 83686, United States
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Samsung Medical Center ( Site 3202)
Seoul, 06351, South Korea
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Sanmenxia Central Hospital ( Site 3360)
Sanmenxia, Henan, 472000, China
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Senders Pediatrics ( Site 0062)
Cleveland, Ohio, 44121, United States
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Seoul National University Bundang Hospital-Pediatrics ( Site 3204)
Seongnam, Kyonggi-do, 13620, South Korea
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Seoul National University Hospital ( Site 3203)
Seoul, 03080, South Korea
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Severance Hospital Yonsei University Health System ( Site 3201)
Seoul, 03722, South Korea
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Shizuoka City Shimizu Hospital ( Site 3061)
Shizuoka, 424-8636, Japan
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Showa University Hospital ( Site 3059)
Tokyo, 142-8666, Japan
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Siriraj Hospital ( Site 3251)
Bangkok, Bangkok, 10700, Thailand
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Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)
Rionegro, Antioquia, 054040, Colombia
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Soroka Medical Center ( Site 2351)
Beersheba, 8410101, Israel
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Soroka University Medical Center Rahat Family health center ( Site 2355)
Rahat, 8535700, Israel
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Soroka University Medical Center Ramot Family health center ( Site 2354)
Beersheba, 8471844, Israel
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Southeastern Pediatric Associates, P.A. ( Site 0008)
Dothan, Alabama, 36303, United States
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Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)
Iași, 700038, Romania
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Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)
Bucharest, 011171, Romania
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Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)
Constanța, 900591, Romania
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Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)
Brasov, 500063, Romania
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Srinagarind Hospital. Khon Kaen University ( Site 3253)
Muang, Changwat Khon Kaen, 40002, Thailand
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St. Georges University Hospital NHS Foundation Trust ( Site 2601)
London, London, City of, SW17 0QT, United Kingdom
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St. Marianna University School of Medicine Hospital ( Site 3060)
Kawasaki, Kanagawa, 216-8511, Japan
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St.Luke's International Hospital ( Site 3062)
Tokyo, 104-8560, Japan
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Steve Biko Academic Hospital ( Site 2505)
Pretoria, Gauteng, 0002, South Africa
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Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)
Warsaw, Masovian Voivodeship, 01-809, Poland
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Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)
Warsaw, Masovian Voivodeship, 00-315, Poland
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Szpital Miejski w Tychach ( Site 2442)
Tychy, Silesian Voivodeship, 43-100, Poland
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Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)
Trzebnica, Lower Silesian Voivodeship, 55-100, Poland
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Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)
Tampere, Pirkanmaa, 33100, Finland
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Tekton Research ( Site 0080)
Chamblee, Georgia, 30341, United States
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The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)
Seoul, 06591, South Korea
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The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)
Bupyeong-gu, Incheon, 21431, South Korea
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The Children's Hospital of Chongqing Medical University ( Site 3333)
Chongqing, Chongqing Municipality, 400065, China
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The First People's Hospital of Hangzhou ( Site 3342)
Hangzhou, Zhejiang, 310006, China
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The Maternal and Child Health Hospital of Hunan Province ( Site 3334)
Changsha, Hunan, 410000, China
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The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)
Guangzhou, Guangdong, 510150, China
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The Third Hospital of Nanchang ( Site 3325)
Nanchang, Jiangxi, 330009, China
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Tottori University Hospital ( Site 3053)
Yonago, Tottori, 683-8504, Japan
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Tribe Clinical Research, LLC ( Site 0015)
Greenville, South Carolina, 29607, United States
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Tygerberg Hospital ( Site 2503)
Cape Town, Western Cape, 7505, South Africa
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UH Bristol Education Centre ( Site 2607)
Bristol, Bristol, City of, BS2 8AE, United Kingdom
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UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)
Pittsburgh, Pennsylvania, 15213, United States
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Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)
Medellín, Antioquia, 050036, Colombia
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Universita degli studi di Padova Patologia e TIN ( Site 2305)
Padua, Veneto, 35128, Italy
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Universitair Ziekenhuis Antwerpen ( Site 2001)
Edegem, Antwerpen, 2650, Belgium
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University Health System- San Antonio ( Site 0048)
San Antonio, Texas, 78229, United States
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University Of The Orange Free State ( Site 2507)
Bloemfontein, Free State, 9301, South Africa
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University of Calgary - Alberta Children Hospital ( Site 0504)
Calgary, Alberta, T3B 6A8, Canada
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University of Texas Medical Branch at Galveston ( Site 0059)
Galveston, Texas, 77555, United States
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University of Utah School of Medicine ( Site 0006)
Salt Lake City, Utah, 84108, United States
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University of the Philippines-Philippine General Hospital ( Site 3152)
Manila, National Capital Region, 1000, Philippines
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Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)
Lublin, Lublin Voivodeship, 20-093, Poland
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Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)
Wroclaw, Lower Silesian Voivodeship, 50-368, Poland
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Uniwersyteckie Centrum Kliniczne ( Site 2437)
Gdansk, Pomeranian Voivodeship, 80-214, Poland
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WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)
Warsaw, Masovian Voivodeship, 00-728, Poland
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Wee Care Pediatrics ( Site 0065)
Syracuse, Utah, 84075, United States
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Wee Care Pediatrics ( Site 0077)
Layton, Utah, 84041, United States
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Wee Care Pediatrics-Roy ( Site 0053)
Roy, Utah, 84067, United States
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Wuhan Children's Hospital ( Site 3329)
Wuhan, Hubei, 430000, China
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Xiamen Maternity and Child Health Care Hospital ( Site 3351)
Xiamen, Fujian, 361003, China
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Xiangya Hospital Central South University ( Site 3347)
Changsha, Hunan, 410008, China
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Yuncheng Central Hospital - Eastern Hospital ( Site 3318)
Yuncheng, Shanxi, 044000, China
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Zhongda Hospital Southeast University ( Site 3353)
Nanjing, Jiangsu, 210009, China
Conditions
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