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COMPLETED
NCT04938830
PHASE3

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

View on ClinicalTrials.gov

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

BIOLOGICAL

Clesrovimab

IM injection

BIOLOGICAL

Palivizumab

IM injection

BIOLOGICAL

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