Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
NCT ID: NCT04938830
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1003 participants
INTERVENTIONAL
2021-11-30
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Clesrovimab
IM injection
Placebo
IM injection
Palivizumab
Participants will receive IM injections.
Palivizumab
IM injection
Interventions
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Clesrovimab
IM injection
Palivizumab
IM injection
Placebo
IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is available to complete the follow-up period.
Exclusion Criteria
* Has a life expectancy \<6 months.
* Has known hepatic or renal dysfunction, or chronic seizure disorder.
* Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
* Has severe immunodeficiency or is severely immunocompromised.
* Has known hypersensitivity to any component of clesrovimab or palivizumab.
1 Year
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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, Moravskoslezský kraj, 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)
Padua, 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 District, , 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
Countries
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References
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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.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-1654-007
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210664
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-500752-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1278-0093
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-005996-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1654-007
Identifier Type: -
Identifier Source: org_study_id
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