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

April 24, 2024 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Misericordiae Limited-Neonatalogy ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 07 3163 8868
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 0863191852
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Active, not recruiting
        • Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • Canadian Center for Vaccinology ( Site 0179)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024708141
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Active, not recruiting
        • CHU Sainte-Justine ( Site 0178)
  • Chile
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 8320325
        • Recruiting
        • Clínica Alemana de Santiago-Neonatology department ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: +56996197211
      • Santiago, Region M. De Santiago, Chile, 8380418
        • Recruiting
        • Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: +56996197211
      • Santiago, Region M. De Santiago, Chile, 8880465
        • Recruiting
        • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: +56994346039
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 50036
        • Recruiting
        • Clínica Universitaria Bolivariana ( Site 0227)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3108239876
      • Medellin, Antioquia, Colombia, 050010
        • Completed
        • Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 08001
        • Recruiting
        • Ciensalud Ips S A S ( Site 0235)
        • Contact:
          • Study Coordinator
          • Phone Number: 573004691661
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 11001000
        • Recruiting
        • Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
        • Contact:
          • Study Coordinator
          • Phone Number: 573008162821
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Recruiting
        • Clínica Imbanaco S.A.S ( Site 0229)
        • Contact:
          • Study Coordinator
          • Phone Number: 573146287331
  • Czechia
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • Active, not recruiting
        • Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
    • Praha 4
      • Prague, Praha 4, Czechia, 14700
        • Active, not recruiting
        • Institute for the Care of Mother and Child ( Site 0251)
  • Finland
    • Mellersta Osterbotten
      • Kokkola, Mellersta Osterbotten, Finland, 67100
        • Completed
        • FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33100
        • Completed
        • FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90220
        • Completed
        • FVR, Oulun rokotetutkimusklinikka ( Site 0303)
    • Sodra Osterbotten
      • Seinajoki, Sodra Osterbotten, Finland, 60100
        • Completed
        • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Active, not recruiting
        • MeVac - Meilahti Vaccine Research Center ( Site 0306)
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Completed
        • FVR, Turun rokotetutkimusklinikka ( Site 0302)
  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Active, not recruiting
        • Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
    • Calvados
      • Caen, Calvados, France, 14033
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
    • Yvelines
      • Le Chesnay, Yvelines, France, 78157
        • Active, not recruiting
        • Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
  • Germany
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany, 79106
        • Active, not recruiting
        • Universitaetsklinikum Freiburg ( Site 0365)
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
        • Contact:
          • Study Coordinator
          • Phone Number: 00496221564606
    • Bayern
      • Munich, Bayern, Germany, 80337
        • Recruiting
        • Dr. von Haunersches Kinderspital ( Site 0358)
        • Contact:
          • Study Coordinator
          • Phone Number: 49-89-44005-7970
      • Munich, Bayern, Germany, 81545
        • Completed
        • München Klinik Harlaching ( Site 0351)
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Completed
        • Medizinische Hochschule Hannover ( Site 0364)
    • Nordrhein-Westfalen
      • Oberhausen, Nordrhein-Westfalen, Germany, 46145
        • Completed
        • Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Completed
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig-Neonatology ( Site 0354)
        • Contact:
          • Study Coordinator
          • Phone Number: 00493419726037
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Completed
        • Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi
        • Contact:
          • Study Coordinator
          • Phone Number: +306974420425
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107793000
      • Chaidari, Attiki, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
        • Contact:
          • Study Coordinator
          • Phone Number: +302105832233
    • Kentriki Makedonia
      • Thessaloniki, Kentriki Makedonia, Greece, 54642
        • Recruiting
        • Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
        • Contact:
          • Study Coordinator
          • Phone Number: +302313312444
  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital ( Site 0926)
        • Contact:
          • Study Coordinator
          • Phone Number: 35052982
      • Tuen Mun, Hong Kong, 999077
        • Recruiting
        • Tuen Mun Hospital ( Site 0927)
        • Contact:
          • Study Coordinator
          • Phone Number: 64680199
  • Hungary
      • Budapest, Hungary, 1076
        • Active, not recruiting
        • Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
      • Budapest, Hungary, 1082
        • Active, not recruiting
        • Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
      • Budapest, Hungary, 1096
        • Active, not recruiting
        • Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 0378)
    • Bacs-Kiskun
      • Baja, Bacs-Kiskun, Hungary
        • Active, not recruiting
        • Bajai Szent Rókus Kórház ( Site 0386)
      • Kecskemét, Bacs-Kiskun, Hungary, 6000
        • Active, not recruiting
        • Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Active, not recruiting
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Active, not recruiting
        • Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)
  • Italy
      • Parma, Italy, 43126
        • Active, not recruiting
        • Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Active, not recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
      • Rome, Lazio, Italy, 00165
        • Active, not recruiting
        • Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
    • Lombardia
      • Milan, Lombardia, Italy, 20154
        • Recruiting
        • ASST Fatebenefratelli Sacco ( Site 0434)
        • Contact:
          • Study Coordinator
          • Phone Number: +39.335.6078053
      • Milano, Lombardia, Italy, 20122
        • Active, not recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Active, not recruiting
        • Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
  • Japan
      • Shizuoka, Japan, 422-8527
        • Completed
        • Shizuoka Saiseikai General Hospital ( Site 0456)
      • Tokyo, Japan, 157-8535
        • Completed
        • National Center for Child Health and Development ( Site 0455)
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 813-0017
        • Completed
        • Fukuoka Children's Hospital ( Site 0452)
      • Iizuka, Fukuoka, Japan, 820-8505
        • Completed
        • Aso Iizuka Hospital ( Site 0457)
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • Completed
        • Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
    • Gunma
      • Maebashi, Gunma, Japan, 371-0811
        • Completed
        • Maebashi Red Cross Hospital ( Site 0451)
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4145
        • Completed
        • Ibaraki Children's Hospital ( Site 0458)
    • Tokyo
      • Itabashiku, Tokyo, Japan, 173-8610
        • Active, not recruiting
        • Nihon University Itabashi Hospital ( Site 0453)
  • Malaysia
      • Kuala Lumpur, Malaysia, 50300
        • Recruiting
        • Hospital Tunku Azizah-Paediatric ( Site 0481)
        • Contact:
          • Study Coordinator
          • Phone Number: +603-26003000
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Recruiting
        • Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
        • Contact:
          • Study Coordinator
          • Phone Number: 6097452636
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
        • Contact:
          • Study Coordinator
          • Phone Number: 60379492260
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang ( Site 0482)
        • Contact:
          • Study Coordinator
          • Phone Number: +60 4-222 5333
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88996
        • Recruiting
        • Sabah Women and Children Hospital ( Site 0478)
        • Contact:
          • Study Coordinator
          • Phone Number: +6088522600
    • Sarawak
      • Sibu, Sarawak, Malaysia, 96000
        • Recruiting
        • Hospital Sibu ( Site 0476)
        • Contact:
          • Study Coordinator
          • Phone Number: 6084314569
  • Mexico
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 6181527904
      • Oaxaca, Mexico, 68000
        • Active, not recruiting
        • Oaxaca Site Management Organization ( Site 0504)
      • San Luis Potosi, Mexico, 78209
        • Completed
        • ONCOLOGICO POTOSINO, S.C. ( Site 0505)
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 04530
        • Active, not recruiting
        • Instituto Nacional de Pediatria ( Site 0506)
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Active, not recruiting
        • Morales Vargas Centro de Investigacion ( Site 0509)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 33 1131 4872
  • New Zealand
      • Auckland, New Zealand, 2025
        • Recruiting
        • Middlemore Clinical Trials ( Site 0526)
        • Contact:
          • Study Coordinator
          • Phone Number: +64925038288952
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Completed
        • Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
  • Norway
      • Oslo, Norway, 0450
        • Active, not recruiting
        • Oslo Universitetssykehus Ullevål ( Site 0551)
  • Peru
      • Lima, Peru, 15001
        • Recruiting
        • HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
        • Contact:
          • Study Coordinator
          • Phone Number: +51999643599
    • Lima
      • Jesús María, Lima, Peru, 15072
        • Recruiting
        • Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
        • Contact:
          • Study Coordinator
          • Phone Number: +51992815948
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • UPR Medical Sciences Campus-Pediatrics ( Site 0626)
        • Contact:
          • Study Coordinator
          • Phone Number: 78775825251576
  • Singapore
    • South West
      • Singapore, South West, Singapore, 229899
        • Recruiting
        • KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
        • Contact:
          • Study Coordinator
          • Phone Number: +65 6225 5554
  • South Africa
    • Gauteng
      • Boksburg, Gauteng, South Africa, 1459
        • Completed
        • Reimed ( Site 0706)
      • Soweto, Gauteng, South Africa, 2013
        • Active, not recruiting
        • Chris Hani Baragwanath Academic Hospital ( Site 0701)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4001
        • Active, not recruiting
        • King Edward VIII Hospital ( Site 0704)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Recruiting
        • Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: 2781466 9392
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
        • Contact:
          • Study Coordinator
          • Phone Number: 27798932840
      • Cape Town, Western Cape, South Africa, 7824
        • Completed
        • 2 Military Hospital ( Site 0708)
      • Cape Town, Western Cape, South Africa, 7500
        • Completed
        • Panorama Medical Centre ( Site 0702)
  • Spain
      • Madrid, Spain, 28046
        • Active, not recruiting
        • Hospital Universitario La Paz ( Site 0726)
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07
      • Malaga, Spain, 29015
        • Active, not recruiting
        • Grupo Pediatrico Uncibay ( Site 0734)
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Active, not recruiting
        • Hospital Universitario Central de Asturias ( Site 0740)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Active, not recruiting
        • Hospital Germans Trias i Pujol ( Site 0738)
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Active, not recruiting
        • Hospital Sant Joan de Déu ( Site 0730)
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Completed
        • Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Completed
        • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
    • Madrid
      • Boadilla del Monte, Madrid, Spain, 28660
        • Recruiting
        • Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 659 33 61 84
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Active, not recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 0754)
        • Contact:
          • Study Coordinator
          • Phone Number: +886933189415
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital-Pediatrics ( Site 0753)
        • Contact:
          • Study Coordinator
          • Phone Number: +886975835388
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital ( Site 0751)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456 ext 71525
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200 ext 8896
  • Thailand
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
        • Active, not recruiting
        • Chulalongkorn University-Pediatrics ( Site 0777)
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Active, not recruiting
        • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Completed
        • Songklanagarind hospital-Department of Pediatrics ( Site 0776)
  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara University Hospital Cebeci ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +905058392717
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi Universitesi ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +905422946435
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 0807)
        • Contact:
          • Study Coordinator
          • Phone Number: 905055668716
      • Kayseri, Turkey, 38030
        • Recruiting
        • Erciyes University Medical Faculty-pediatric infection ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +905057011878
    • Adana
      • Sarçam, Adana, Turkey, 01030
        • Recruiting
        • cukurova universty ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: +905326534166
  • United Kingdom
      • Liverpool, United Kingdom, L12 2AP
        • Completed
        • Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
    • England
      • London, England, United Kingdom, E11 1NR
        • Recruiting
        • Whipps Cross University Hospital ( Site 0846)
        • Contact:
          • Study Coordinator
          • Phone Number: 02085395522
      • London, England, United Kingdom, SW17 0RE
        • Recruiting
        • St. George's Hospital ( Site 0845)
        • Contact:
          • Study Coordinator
          • Phone Number: 02087252788
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Recruiting
        • Queen Elizabeth University Hospital ( Site 0842)
        • Contact:
          • Study Coordinator
          • Phone Number: 01414514887
    • Great Britain
      • London, Great Britain, United Kingdom, SE1 7EH
        • Recruiting
        • Evelina London Children's Hospital ( Site 0829)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7188 7188
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Active, not recruiting
        • Southampton General Hospital ( Site 0826)
    • London, City Of
      • London, London, City Of, United Kingdom, E1 1BB
        • Recruiting
        • Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
        • Contact:
          • Study Coordinator
          • Phone Number: 447801968718
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
        • Contact:
          • Study Coordinator
          • Phone Number: 447831638192
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Completed
        • Miller Children's & Women's Hospital Long Beach ( Site 0001)
      • Orange, California, United States, 92868
        • Completed
        • Children's Hospital of Orange County ( Site 0047)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Completed
        • Children's Hospital Colorado ( Site 0011)
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-276-4293
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M
        • Contact:
          • Study Coordinator
          • Phone Number: 321-841-6350
      • Orlando, Florida, United States, 32827
        • Completed
        • Nemours Children's Health, Lake Nona Medical City ( Site 0032)
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida-Department of Pediatrics ( Site 0045)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-832-4946
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School Of Medicine ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-778-6532
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Completed
        • Clinical Research Prime ( Site 0046)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Completed
        • University of Kentucky HealthCare - Turfland ( Site 0044)
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Completed
        • Our Lady of the Lake Children's Hospital ( Site 0031)
      • New Orleans, Louisiana, United States, 70112
        • Completed
        • Tulane University School of Medicine ( Site 0010)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Completed
        • M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Completed
        • Rutgers University-Pediatric Clinical Research Center ( Site 0007)
    • New York
      • Mineola, New York, United States, 11501
        • Completed
        • NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center ( Site 0017)
        • Contact:
          • Study Coordinator
          • Phone Number: 585-275-2981
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Completed
        • The University of North Carolina at Chapel Hill ( Site 0035)
      • Durham, North Carolina, United States, 27710
        • Active, not recruiting
        • Duke University ( Site 0021)
    • Ohio
      • Dayton, Ohio, United States, 45449
        • Completed
        • Dayton Children's Hospital ( Site 0053)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Tribe Clinical Research, LLC ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 864-334-0141
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Driscoll Children's Hospital ( Site 0025)
        • Contact:
          • Study Coordinator
          • Phone Number: 361-739-8496
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • DHR Health Institute for Research and Development ( Site 0029)
        • Contact:
          • Study Coordinator
          • Phone Number: 956-802-8855
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University Hospital-Pediatrics ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-254-6317
      • San Antonio, Texas, United States, 78249
        • Recruiting
        • Road Runner Research, Ltd ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-949-0505
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Christus Children's-Clinical Research Center ( Site 0038)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-704-2472
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Completed
        • Intermountain - Primary Children's Hospital ( Site 0026)
    • Washington
      • Spokane, Washington, United States, 99204
        • Active, not recruiting
        • Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
      • Spokane, Washington, United States, 99202
        • Completed
        • Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
      • Tacoma, Washington, United States, 98405
        • Completed
        • MultiCare Health System-Baker Center ( Site 0036)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
  • Is available to complete the follow-up period.

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 7 days after randomization.
  • Has severe immunodeficiency or is severely immunocompromised.
  • Has known hypersensitivity to any component of clesrovimab or palivizumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Biological: Clesrovimab
IM injection
Other Names:
  • MK-1654
Biological: Placebo
IM injection
Active Comparator: Palivizumab
Participants will receive IM injections.
Biological: Palivizumab
IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
Time Frame: Up to 5 days
Percentage of participants with solicited injection-site AEs in RSV Season 1
Up to 5 days
Participants with solicited daily body temperature with fever in RSV Season 1
Time Frame: Up to 5 days
Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Up to 5 days
Participants with solicited systemic AEs in RSV Season 1
Time Frame: Up to 5 days
Percentage of participants with solicited systemic AEs in RSV Season 1
Up to 5 days
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Time Frame: Up to 42 days
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Up to 42 days
Participants with rash AESI in RSV Season 1
Time Frame: Up to 42 days
Percentage of participants with rash AESI in RSV Season 1
Up to 42 days
Participants with non-serious AEs in RSV Season 1
Time Frame: Up to 42 days
Percentage of participants with non-serious AEs in RSV Season 1
Up to 42 days
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Time Frame: Up to 365 days
Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Up to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Time Frame: Up to 150 days
Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Up to 150 days
Participants with RSV-associated hospitalization in RSV Season 1
Time Frame: Up to 150 days
Percentage of participants with RSV-associated hospitalization in RSV Season 1
Up to 150 days
Participants with solicited injection-site AEs in RSV Season 2
Time Frame: From approximately 393 days up to 400 days
Percentage of participants with solicited injection-site AEs in RSV Season 2
From approximately 393 days up to 400 days
Participants with solicited daily body temperature with fever in RSV Season 2
Time Frame: From approximately 393 days up to 400 days
Percentage of participants with solicited daily body temperature with fever in RSV Season 2
From approximately 393 days up to 400 days
Participants with solicited systemic AEs in RSV Season 2
Time Frame: From approximately 393 days up to 400 days
Percentage of participants with solicited systemic AEs in RSV Season 2
From approximately 393 days up to 400 days
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Time Frame: From approximately 393 days up to 440 days
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
From approximately 393 days up to 440 days
Participants with rash AESI in RSV Season 2
Time Frame: From approximately 393 days up to 440 days
Percentage of participants with rash AESI in RSV Season 2
From approximately 393 days up to 440 days
Participants with non-serious AEs in RSV Season 2
Time Frame: From approximately 393 days up to 440 days
Percentage of participants with non-serious AEs in RSV Season 2
From approximately 393 days up to 440 days
Participants with SAEs in RSV Season 2
Time Frame: From approximately 393 days up to 575 days
Percentage of participants with SAEs in RSV Season 2
From approximately 393 days up to 575 days
Concentration of clesrovimab in RSV Season 1
Time Frame: Up to 240 days
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1
Up to 240 days
Concentration of clesrovimab in RSV Season 2
Time Frame: From approximately 393 days up to 550 days
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
From approximately 393 days up to 550 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

June 28, 2025

Study Completion (Estimated)

January 6, 2026

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1654-007
  • MK-1654-007 (Other Identifier: Merck)
  • jRCT2031210664 (Registry Identifier: jRCT)
  • 2020-005996-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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