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Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Sponsor: Merck Sharp & Dohme LLC
Summary
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
Official title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Key Details
Gender
All
Age Range
Any - 1 Year
Study Type
INTERVENTIONAL
Enrollment
1003
Start Date
2021-11-30
Completion Date
2025-08-01
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Clesrovimab
IM injection
Palivizumab
IM injection
Placebo
IM injection
Locations (146)
Miller Children's & Women's Hospital Long Beach ( Site 0001)
Long Beach, California, United States
Children's Hospital of Orange County ( Site 0047)
Orange, California, United States
Children's Hospital Colorado ( Site 0011)
Aurora, Colorado, United States
Children's National Medical Center ( Site 0020)
Washington D.C., District of Columbia, United States
Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
Orlando, Florida, United States
Nemours Children's Health, Lake Nona Medical City ( Site 0032)
Orlando, Florida, United States
University of South Florida-Department of Pediatrics ( Site 0045)
Tampa, Florida, United States
Morehouse School Of Medicine ( Site 0049)
Atlanta, Georgia, United States
Clinical Research Prime ( Site 0046)
Idaho Falls, Idaho, United States
University of Kentucky HealthCare - Turfland ( Site 0044)
Lexington, Kentucky, United States
Our Lady of the Lake Children's Hospital ( Site 0031)
Baton Rouge, Louisiana, United States
Tulane University School of Medicine ( Site 0010)
New Orleans, Louisiana, United States
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037)
Minneapolis, Minnesota, United States
Rutgers University-Pediatric Clinical Research Center ( Site 0007)
New Brunswick, New Jersey, United States
NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
Mineola, New York, United States
University of Rochester Medical Center ( Site 0017)
Rochester, New York, United States
The University of North Carolina at Chapel Hill ( Site 0035)
Chapel Hill, North Carolina, United States
Duke University ( Site 0021)
Durham, North Carolina, United States
Dayton Children's Hospital ( Site 0053)
Dayton, Ohio, United States
Tribe Clinical Research, LLC ( Site 0002)
Greenville, South Carolina, United States
Driscoll Children's Hospital ( Site 0025)
Corpus Christi, Texas, United States
DHR Health Institute for Research and Development ( Site 0029)
Edinburg, Texas, United States
Christus Children's-Clinical Research Center ( Site 0038)
San Antonio, Texas, United States
University Hospital-Pediatrics ( Site 0019)
San Antonio, Texas, United States
Road Runner Research, Ltd ( Site 0052)
San Antonio, Texas, United States
Intermountain - Primary Children's Hospital ( Site 0026)
Salt Lake City, Utah, United States
Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
Spokane, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
Spokane, Washington, United States
MultiCare Health System-Baker Center ( Site 0036)
Tacoma, Washington, United States
Mater Misericordiae Limited-Neonatalogy ( Site 0102)
Brisbane, Queensland, Australia
Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
Nedlands, Western Australia, Australia
Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
Calgary, Alberta, Canada
Canadian Center for Vaccinology ( Site 0179)
Halifax, Nova Scotia, Canada
CHU Sainte-Justine ( Site 0178)
Montreal, Quebec, Canada
Clínica Alemana de Santiago-Neonatology department ( Site 0207)
Santiago, Region M. de Santiago, Chile
Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
Santiago, Region M. de Santiago, Chile
Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
Santiago, Region M. de Santiago, Chile
Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
Medellín, Antioquia, Colombia
Clínica Universitaria Bolivariana ( Site 0227)
Medellín, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0235)
Barranquilla, Atlántico, Colombia
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
Bogotá, Bogota D.C., Colombia
Clínica Imbanaco S.A.S ( Site 0229)
Cali, Valle del Cauca Department, Colombia
Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
Ostrava, Moravian-Silesian Region, Czechia
Institute for the Care of Mother and Child ( Site 0251)
Prague, Praha 4, Czechia
FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
Kokkola, Keski-Pohjanmaa, Finland
FVR, Oulun rokotetutkimusklinikka ( Site 0303)
Oulu, North Ostrobothnia, Finland
FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
Tampere, Pirkanmaa, Finland
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
Seinäjoki, South Ostrobothnia, Finland
FVR, Turun rokotetutkimusklinikka ( Site 0302)
Turku, Southwest Finland, Finland
MeVac - Meilahti Vaccine Research Center ( Site 0306)
Helsinki, Uusimaa, Finland
Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
Bordeaux, Aquitaine, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330)
Caen, Calvados, France
Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
Le Chesnay, Yvelines, France
Universitaetsklinikum Freiburg ( Site 0365)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
Heidelberg, Baden-Wurttemberg, Germany
Dr. von Haunersches Kinderspital ( Site 0358)
Munich, Bavaria, Germany
München Klinik Harlaching ( Site 0351)
Munich, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0364)
Hanover, Lower Saxony, Germany
Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
Oberhausen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
Dresden, Saxony, Germany
Universitätsklinikum Leipzig-Neonatology ( Site 0354)
Leipzig, Saxony, Germany
Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
Lübeck, Schleswig-Holstein, Germany
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
Athens, Attica, Greece
Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
Chaïdári, Attica, Greece
Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
Thessaloniki, Central Macedonia, Greece
Prince of Wales Hospital ( Site 0926)
Shatin, Hong Kong
Tuen Mun Hospital ( Site 0927)
Tuenmen, Hong Kong
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bajai Szent Rókus Kórház ( Site 0386)
Baja, Bács-Kiskun county, Hungary
Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
Kecskemét, Bács-Kiskun county, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
Budapest, Hungary
Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
Budapest, Hungary
Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0378)
Debrecen, Hungary
Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
Milan, Lombardy, Italy
ASST Fatebenefratelli Sacco ( Site 0434)
Milan, Lombardy, Italy
Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
Padova, Veneto, Italy
Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
Parma, Italy
Fukuoka Children's Hospital ( Site 0452)
Fukuoka, Fukuoka, Japan
Iizuka Hospital ( Site 0457)
Iizuka, Fukuoka, Japan
Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
Kitakyushu-shi, Fukuoka, Japan
Maebashi Red Cross Hospital ( Site 0451)
Maebashi, Gunma, Japan
Ibaraki Children's Hospital ( Site 0458)
Mito, Ibaraki, Japan
Nihon University Itabashi Hospital ( Site 0453)
Itabashiku, Tokyo, Japan
Shizuoka Saiseikai General Hospital ( Site 0456)
Shizuoka, Japan
National Center for Child Health and Development ( Site 0455)
Tokyo, Japan
Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Pulau Pinang ( Site 0482)
George Town, Pulau Pinang, Malaysia
Sabah Women and Children Hospital ( Site 0478)
Kota Kinabalu, Sabah, Malaysia
Hospital Sibu ( Site 0476)
Sibu, Sarawak, Malaysia
Hospital Tunku Azizah-Paediatric ( Site 0481)
Kuala Lumpur, Malaysia
Morales Vargas Centro de Investigacion ( Site 0509)
León, Guanajuato, Mexico
Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria ( Site 0506)
Mexico City, Mexico City, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
Durango, Mexico
Oaxaca Site Management Organization ( Site 0504)
Oaxaca City, Mexico
ONCOLOGICO POTOSINO, S.C. ( Site 0505)
San Luis Potosí City, Mexico
Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
Newtown, Wellington Region, New Zealand
Middlemore Clinical Trials ( Site 0526)
Auckland, New Zealand
Oslo Universitetssykehus Ullevål ( Site 0551)
Oslo, Norway
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
Jesús María, Lima, Peru
HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
Lima, Peru
UPR Medical Sciences Campus-Pediatrics ( Site 0626)
San Juan, Puerto Rico
KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
Singapore, South West, Singapore
Reimed ( Site 0706)
Boksburg, Gauteng, South Africa
Chris Hani Baragwanath Academic Hospital ( Site 0701)
Soweto, Gauteng, South Africa
King Edward VIII Hospital ( Site 0704)
Durban, KwaZulu-Natal, South Africa
Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
Cape Town, Western Cape, South Africa
Panorama Medical Centre ( Site 0702)
Cape Town, Western Cape, South Africa
MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
Cape Town, Western Cape, South Africa
2 Military Hospital ( Site 0708)
Cape Town, Western Cape, South Africa
Hospital Germans Trias i Pujol ( Site 0738)
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu ( Site 0730)
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
Sant Cugat del Vallès, Barcelona, Spain
CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
Santiago de Compostela, La Coruna, Spain
Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
Boadilla del Monte, Madrid, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias ( Site 0740)
Oviedo, Principality of Asturias, Spain
Hospital Universitario La Paz ( Site 0726)
Madrid, Spain
Grupo Pediatrico Uncibay ( Site 0734)
Málaga, Spain
Taichung Veterans General Hospital ( Site 0754)
Taichung, Taiwan
National Taiwan University Hospital ( Site 0751)
Taipei, Taiwan
Mackay Memorial Hospital-Pediatrics ( Site 0753)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
Taoyuan, Taiwan
Chulalongkorn University-Pediatrics ( Site 0777)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
Bangkok, Bangkok, Thailand
Songklanagarind hospital-Department of Pediatrics ( Site 0776)
Hat Yai, Changwat Songkhla, Thailand
cukurova universty ( Site 0805)
Sarçam, Adana, Turkey (Türkiye)
Ankara University Hospital Cebeci ( Site 0801)
Ankara, Turkey (Türkiye)
Gazi Universitesi ( Site 0806)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 0807)
Ankara, Turkey (Türkiye)
Erciyes University Medical Faculty-pediatric infection ( Site 0804)
Kayseri, Turkey (Türkiye)
Whipps Cross University Hospital ( Site 0846)
London, England, United Kingdom
St. George's Hospital ( Site 0845)
London, England, United Kingdom
Queen Elizabeth University Hospital ( Site 0842)
Glasgow, Glasgow City, United Kingdom
Evelina London Children's Hospital ( Site 0829)
London, Great Britain, United Kingdom
Southampton General Hospital ( Site 0826)
Southampton, Hampshire, United Kingdom
Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
London, London, City of, United Kingdom
The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
Oxford, Oxfordshire, United Kingdom
Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
Liverpool, United Kingdom