Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Last updated: March 17, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

Placebo

Clesrovimab

Palivizumab

Clinical Study ID

NCT04938830
1654-007
2020-005996-11
U1111-1278-0093
MK-1654-007
2022-500752-39
jRCT2031210664
  • Ages < 1
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants at increased risk for severe RSV infection recommended to receivepalivizumab in accordance with national or local guidelines or professional societyrecommendations.

  • Is available to complete the follow-up period.

Exclusion

Exclusion Criteria:

  • Requires mechanical ventilation at time of enrollment.

  • 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 7days after randomization.

  • Has severe immunodeficiency or is severely immunocompromised.

  • Has known hypersensitivity to any component of clesrovimab or palivizumab.

Study Design

Total Participants: 1000
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 30, 2021
Estimated Completion Date:
August 13, 2025

Connect with a study center

  • Mater Misericordiae Limited-Neonatalogy ( Site 0102)

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Telethon Kids Institute-Vaccine Trials Group ( Site 0101)

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Alberta Children's Hospital-Department of Pediatrics ( Site 0180)

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Canadian Center for Vaccinology ( Site 0179)

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • CHU Sainte-Justine ( Site 0178)

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Clínica Alemana de Santiago-Neonatology department ( Site 0207)

    Santiago, Region M. De Santiago 8320325
    Chile

    Site Not Available

  • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)

    Santiago, Region M. De Santiago 8880465
    Chile

    Site Not Available

  • Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)

    Santiago, Region M. De Santiago 8380418
    Chile

    Site Not Available

  • Clínica Universitaria Bolivariana ( Site 0227)

    Medellin, Antioquia 50036
    Colombia

    Site Not Available

  • Fundación Hospitalaria San Vicente de Paúl ( Site 0233)

    Medellin, Antioquia 050010
    Colombia

    Site Not Available

  • Ciensalud Ips S A S ( Site 0235)

    Barranquilla, Atlantico 08001
    Colombia

    Site Not Available

  • Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)

    Bogota, Distrito Capital De Bogota 11001000
    Colombia

    Site Not Available

  • Clínica Imbanaco S.A.S ( Site 0229)

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)

    Ostrava, Moravskoslezsky Kraj 708 52
    Czechia

    Site Not Available

  • Institute for the Care of Mother and Child ( Site 0251)

    Prague, Praha 4 14700
    Czechia

    Site Not Available

  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)

    Kokkola, Mellersta Osterbotten 67100
    Finland

    Site Not Available

  • FVR, Tampereen rokotetutkimusklinikka ( Site 0301)

    Tampere, Pirkanmaa 33100
    Finland

    Site Not Available

  • FVR, Oulun rokotetutkimusklinikka ( Site 0303)

    Oulu, Pohjois-Pohjanmaa 90220
    Finland

    Site Not Available

  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)

    Seinajoki, Sodra Osterbotten 60100
    Finland

    Site Not Available

  • Seinjoki Vaccine Research Center ( Site 0305)

    Seinäjoki, Sodra Osterbotten 60100
    Finland

    Site Not Available

  • MeVac - Meilahti Vaccine Research Center ( Site 0306)

    Helsinki, Uusimaa 00290
    Finland

    Site Not Available

  • FVR, Turun rokotetutkimusklinikka ( Site 0302)

    Turku, Varsinais-Suomi 20520
    Finland

    Site Not Available

  • Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

    Caen, Calvados 14033
    France

    Site Not Available

  • Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)

    Le Chesnay, Yvelines 78157
    France

    Site Not Available

  • Universitaetsklinikum Freiburg ( Site 0365)

    Freiburg, Baden-Wurttemberg 79106
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)

    Heidelberg, Baden-Wurttemberg 69120
    Germany

    Site Not Available

  • Dr. von Haunersches Kinderspital ( Site 0358)

    Munich, Bayern 80337
    Germany

    Site Not Available

  • München Klinik Harlaching ( Site 0351)

    Munich, Bayern 81545
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover ( Site 0364)

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)

    Oberhausen, Nordrhein-Westfalen 46145
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig-Neonatology ( Site 0354)

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi

    Athens, Attiki 115 27
    Greece

    Site Not Available

  • Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)

    Athens, Attiki 115 27
    Greece

    Site Not Available

  • ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)

    Chaidari, Attiki 124 62
    Greece

    Site Not Available

  • Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)

    Thessaloniki, Kentriki Makedonia 54642
    Greece

    Site Not Available

  • Prince of Wales Hospital ( Site 0926)

    Shatin,
    Hong Kong

    Site Not Available

  • Tuen Mun Hospital ( Site 0927)

    Tuen Mun, 999077
    Hong Kong

    Site Not Available

  • Bajai Szent Rókus Kórház ( Site 0386)

    Baja, Bacs-Kiskun
    Hungary

    Site Not Available

  • Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)

    Kecskemét, Bacs-Kiskun 6000
    Hungary

    Site Not Available

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si

    Miskolc, Borsod-Abauj-Zemplen 3526
    Hungary

    Site Not Available

  • Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Site Not Available

  • Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)

    Budapest, 1096
    Hungary

    Site Not Available

  • Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)

    Budapest, 1076
    Hungary

    Site Not Available

  • Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)

    Budapest, 1082
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont ( Site 0378)

    Debrecen, 4032
    Hungary

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)

    Rome, Lazio 00165
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco ( Site 0434)

    Milan, Lombardia 20154
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 0427)

    Rome, Roma 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù-UOC Broncopneumologia ( Site 0427)

    Rome, Roma 00165
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)

    Parma, 43126
    Italy

    Site Not Available

  • Fukuoka Children's Hospital ( Site 0452)

    Fukuoka-shi, Fukuoka 813-0017
    Japan

    Site Not Available

  • Aso Iizuka Hospital ( Site 0457)

    Iizuka, Fukuoka 820-8505
    Japan

    Site Not Available

  • Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)

    Kitakyushu-shi, Fukuoka 806-8501
    Japan

    Site Not Available

  • Maebashi Red Cross Hospital ( Site 0451)

    Maebashi, Gunma 371-0811
    Japan

    Site Not Available

  • Ibaraki Children's Hospital ( Site 0458)

    Mito, Ibaraki 311-4145
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital ( Site 0453)

    Itabashiku, Tokyo 173-8610
    Japan

    Site Not Available

  • Shizuoka Saiseikai General Hospital ( Site 0456)

    Shizuoka, 422-8527
    Japan

    Site Not Available

  • National Center for Child Health and Development ( Site 0455)

    Tokyo, 157-8535
    Japan

    Site Not Available

  • Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)

    Kota Bharu, Kelantan 15586
    Malaysia

    Site Not Available

  • University Malaya Medical Centre-Department of Paediatrics ( Site 0480)

    Lembah Pantai, Kuala Lumpur 59100
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang ( Site 0482)

    George Town, Pulau Pinang 10990
    Malaysia

    Site Not Available

  • Sabah Women and Children Hospital ( Site 0478)

    Kota Kinabalu, Sabah 88996
    Malaysia

    Site Not Available

  • Hospital Sibu ( Site 0476)

    Sibu, Sarawak 96000
    Malaysia

    Site Not Available

  • Hospital Tunku Azizah-Paediatric ( Site 0481)

    Kuala Lumpur, 50300
    Malaysia

    Site Not Available

  • Instituto Nacional de Pediatria ( Site 0506)

    Mexico City, Distrito Federal 04530
    Mexico

    Site Not Available

  • Morales Vargas Centro de Investigacion ( Site 0509)

    León, Guanajuato 37000
    Mexico

    Site Not Available

  • Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)

    Durango, 34000
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization ( Site 0504)

    Oaxaca, 68000
    Mexico

    Site Not Available

  • ONCOLOGICO POTOSINO, S.C. ( Site 0505)

    San Luis Potosi, 78209
    Mexico

    Site Not Available

  • Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)

    Newtown, Wellington 6021
    New Zealand

    Site Not Available

  • Middlemore Clinical Trials ( Site 0526)

    Auckland, 2025
    New Zealand

    Site Not Available

  • Oslo Universitetssykehus Ullevål ( Site 0551)

    Oslo, 0450
    Norway

    Site Not Available

  • Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)

    Jesús María, Lima 15072
    Peru

    Site Not Available

  • HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)

    Lima, 15001
    Peru

    Site Not Available

  • UPR Medical Sciences Campus-Pediatrics ( Site 0626)

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)

    Singapore, South West 229899
    Singapore

    Site Not Available

  • Reimed ( Site 0706)

    Boksburg, Gauteng 1459
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Academic Hospital ( Site 0701)

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • King Edward VIII Hospital ( Site 0704)

    Durban, Kwazulu-Natal 4001
    South Africa

    Site Not Available

  • 2 Military Hospital ( Site 0708)

    Cape Town, Western Cape 7824
    South Africa

    Site Not Available

  • Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)

    Cape Town, Western Cape 7500
    South Africa

    Site Not Available

  • MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)

    Cape Town, Western Cape 7700
    South Africa

    Site Not Available

  • Panorama Medical Centre ( Site 0702)

    Cape Town, Western Cape 7500
    South Africa

    Site Not Available

  • Hospital Universitario Central de Asturias ( Site 0740)

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol ( Site 0738)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu ( Site 0730)

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)

    Sant Cugat del Vallès, Barcelona 08195
    Spain

    Site Not Available

  • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)

    Santiago de Compostela, La Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)

    Boadilla del Monte, Madrid 28660
    Spain

    Site Not Available

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 0726)

    Madrid, 28046
    Spain

    Site Not Available

  • Grupo Pediatrico Uncibay ( Site 0734)

    Malaga, 29015
    Spain

    Site Not Available

  • Taichung Veterans General Hospital ( Site 0754)

    Taichung, 407
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital-Pediatrics ( Site 0753)

    Taipei, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 0751)

    Taipei, 100225
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0752)

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chulalongkorn University-Pediatrics ( Site 0777)

    Bangkok, Krung Thep Maha Nakhon 10330
    Thailand

    Site Not Available

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • Songklanagarind hospital-Department of Pediatrics ( Site 0776)

    Hat Yai, Songkhla 90110
    Thailand

    Site Not Available

  • cukurova universty ( Site 0805)

    Sarçam, Adana 01030
    Turkey

    Site Not Available

  • Ankara Bilkent Şehir Hastanesi. ( Site 0807)

    Ankara, 06800
    Turkey

    Site Not Available

  • Ankara City Hospital ( Site 0807)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Ankara University Hospital Cebeci ( Site 0801)

    Ankara, 06100
    Turkey

    Site Not Available

  • Gazi Universitesi ( Site 0806)

    Ankara, 06560
    Turkey

    Site Not Available

  • Erciyes University Medical Faculty-pediatric infection ( Site 0804)

    Kayseri, 38030
    Turkey

    Site Not Available

  • St. George's Hospital ( Site 0845)

    London, England SW17 0RE
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital ( Site 0846)

    London, England E11 1NR
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital ( Site 0842)

    Glasgow, Glasgow City G51 4TF
    United Kingdom

    Site Not Available

  • Evelina London Children's Hospital ( Site 0829)

    London, Great Britain SE1 7EH
    United Kingdom

    Site Not Available

  • Southampton General Hospital ( Site 0826)

    Southampton, Hampshire SO16 0YD
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)

    London, London, City Of E1 1BB
    United Kingdom

    Site Not Available

  • The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Miller Children's & Women's Hospital Long Beach ( Site 0001)

    Long Beach, California 90806
    United States

    Site Not Available

  • Children's Hospital of Orange County ( Site 0047)

    Orange, California 92868
    United States

    Site Not Available

  • Children's Hospital Colorado ( Site 0011)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's National Medical Center ( Site 0020)

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Nemours Children's Health, Lake Nona Medical City ( Site 0032)

    Orlando, Florida 32827
    United States

    Site Not Available

  • Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M

    Orlando, Florida 32806
    United States

    Site Not Available

  • University of South Florida-Department of Pediatrics ( Site 0045)

    Tampa, Florida 33606
    United States

    Site Not Available

  • Morehouse School Of Medicine ( Site 0049)

    Atlanta, Georgia 30310
    United States

    Site Not Available

  • Clinical Research Prime ( Site 0046)

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • University of Kentucky HealthCare - Turfland ( Site 0044)

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Our Lady of the Lake Children's Hospital ( Site 0031)

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Tulane University School of Medicine ( Site 0010)

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

  • Rutgers University-Pediatric Clinical Research Center ( Site 0007)

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)

    Mineola, New York 11501
    United States

    Site Not Available

  • University of Rochester Medical Center ( Site 0017)

    Rochester, New York 14642
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill ( Site 0035)

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University ( Site 0021)

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Dayton Children's Hospital ( Site 0053)

    Dayton, Ohio 45449
    United States

    Site Not Available

  • Tribe Clinical Research, LLC ( Site 0002)

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Driscoll Children's Hospital ( Site 0025)

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • DHR Health Institute for Research and Development ( Site 0029)

    Edinburg, Texas 78539
    United States

    Site Not Available

  • Christus Children's-Clinical Research Center ( Site 0038)

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Road Runner Research, Ltd ( Site 0052)

    San Antonio, Texas 78249
    United States

    Site Not Available

  • The Children's Hospital of San Antonio ( Site 0038)

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • University Hospital-Pediatrics ( Site 0019)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Intermountain - Primary Children's Hospital ( Site 0026)

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)

    Spokane, Washington 99202
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)

    Spokane, Washington 99204
    United States

    Site Not Available

  • MultiCare Health System-Baker Center ( Site 0036)

    Tacoma, Washington 98405
    United States

    Site Not Available

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