Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) | NCT04938830 | Trialant

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) | NCT04938830 | Trialant

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group.

Is available to complete the follow-up period.

Additional inclusion criteria for participation in RSV Season 2:

RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season 1. Participants with CHD must also have the following:

Hemodynamically significant CHD at the beginning of RSV Season 2, or

If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD.

RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following:

Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough

Down Syndrome (trisomy of chromosome 21)

Cystic fibrosis with nutritional compromise

Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease

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.

Additional exclusion criteria for participation in RSV Season 2:

Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.

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

Long Beach, California 90806, United States

Children's Hospital of Orange County ( Site 0047)

Orange, California 92868, United States

Children's Hospital Colorado ( Site 0011)

Aurora, Colorado 80045, United States

Children's National Medical Center ( Site 0020)

Washington D.C., District of Columbia 20010, United States

Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)

Orlando, Florida 32806, United States

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

Orlando, Florida 32827, United States

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

Tampa, Florida 33606, United States

Morehouse School Of Medicine ( Site 0049)

Atlanta, Georgia 30310, United States

Clinical Research Prime ( Site 0046)

Idaho Falls, Idaho 83404, United States

University of Kentucky HealthCare - Turfland ( Site 0044)

Lexington, Kentucky 40536, United States

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

Baton Rouge, Louisiana 70809, United States

Tulane University School of Medicine ( Site 0010)

New Orleans, Louisiana 70112, United States

M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037)

Minneapolis, Minnesota 55454, United States

Rutgers University-Pediatric Clinical Research Center ( Site 0007)

New Brunswick, New Jersey 08901, United States

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

Mineola, New York 11501, United States

University of Rochester Medical Center ( Site 0017)

Rochester, New York 14642, United States

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

Chapel Hill, North Carolina 27514, United States

Duke University ( Site 0021)

Durham, North Carolina 27710, United States

Dayton Children's Hospital ( Site 0053)

Dayton, Ohio 45449, United States

Tribe Clinical Research, LLC ( Site 0002)

Greenville, South Carolina 29607, United States

Driscoll Children's Hospital ( Site 0025)

Corpus Christi, Texas 78411, United States

DHR Health Institute for Research and Development ( Site 0029)

Edinburg, Texas 78539, United States

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

San Antonio, Texas 78207, United States

University Hospital-Pediatrics ( Site 0019)

San Antonio, Texas 78229, United States

Road Runner Research, Ltd ( Site 0052)

San Antonio, Texas 78249, United States

Intermountain - Primary Children's Hospital ( Site 0026)

Salt Lake City, Utah 84113, United States

Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)

Spokane, Washington 99202, United States

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

Spokane, Washington 99204, United States

MultiCare Health System-Baker Center ( Site 0036)

Tacoma, Washington 98405, United States

Mater Misericordiae Limited-Neonatalogy ( Site 0102)

Brisbane, Queensland 4101, Australia

Telethon Kids Institute-Vaccine Trials Group ( Site 0101)

Nedlands, Western Australia 6009, Australia

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

Calgary, Alberta T3B 6A8, Canada

Canadian Center for Vaccinology ( Site 0179)

Halifax, Nova Scotia B3K 6R8, Canada

CHU Sainte-Justine ( Site 0178)

Montreal, Quebec H3T 1C5, Canada

Clínica Alemana de Santiago-Neonatology department ( Site 0207)

Santiago, Region M. de Santiago 8320325, Chile

Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)

Santiago, Region M. de Santiago 8380418, Chile

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)

Santiago, Region M. de Santiago 8880465, Chile

Fundación Hospitalaria San Vicente de Paúl ( Site 0233)

Medellín, Antioquia 050010, Colombia

Clínica Universitaria Bolivariana ( Site 0227)

Medellín, Antioquia 50036, Colombia

Ciensalud Ips S A S ( Site 0235)

Barranquilla, Atlántico 08001, Colombia

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

Bogotá, Bogota D.C. 111411, Colombia

Clínica Imbanaco S.A.S ( Site 0229)

Cali, Valle del Cauca Department 760042, Colombia

Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)

Ostrava, Moravian-Silesian Region 708 52, Czechia

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

Prague, Praha 4 14700, Czechia

FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)

Kokkola, Keski-Pohjanmaa 67100, Finland

FVR, Oulun rokotetutkimusklinikka ( Site 0303)

Oulu, North Ostrobothnia 90220, Finland

FVR, Tampereen rokotetutkimusklinikka ( Site 0301)

Tampere, Pirkanmaa 33100, Finland

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)

Seinäjoki, South Ostrobothnia 60100, Finland

FVR, Turun rokotetutkimusklinikka ( Site 0302)

Turku, Southwest Finland 20520, Finland

MeVac - Meilahti Vaccine Research Center ( Site 0306)

Helsinki, Uusimaa 00290, Finland

Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)

Bordeaux, Aquitaine 33076, France

Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330)

Caen, Calvados 14033, France

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

Le Chesnay, Yvelines 78157, France

Universitaetsklinikum Freiburg ( Site 0365)

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

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

Heidelberg, Baden-Wurttemberg 69120, Germany

Dr. von Haunersches Kinderspital ( Site 0358)

Munich, Bavaria 80337, Germany

München Klinik Harlaching ( Site 0351)

Munich, Bavaria 81545, Germany

Medizinische Hochschule Hannover ( Site 0364)

Hanover, Lower Saxony 30625, Germany

Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)

Oberhausen, North Rhine-Westphalia 46145, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)

Dresden, Saxony 01307, Germany

Universitätsklinikum Leipzig-Neonatology ( Site 0354)

Leipzig, Saxony 04103, Germany

Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)

Lübeck, Schleswig-Holstein 23538, Germany

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)

Athens, Attica 115 27, Greece

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

Athens, Attica 115 27, Greece

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

Chaïdári, Attica 124 62, Greece

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

Thessaloniki, Central Macedonia 54642, Greece

Prince of Wales Hospital ( Site 0926)

Shatin, Hong Kong

Tuen Mun Hospital ( Site 0927)

Tuenmen, 999077, Hong Kong

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388)

Miskolc, Borsod-Abauj Zemplen county 3526, Hungary

Bajai Szent Rókus Kórház ( Site 0386)

Baja, Bács-Kiskun county, Hungary

Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)

Kecskemét, Bács-Kiskun county 6000, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)

Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary

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

Budapest, 1076, Hungary

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

Budapest, 1082, Hungary

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)

Budapest, 1096, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0378)

Debrecen, 4032, Hungary

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

Rome, Lazio 00165, Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)

Rome, Lazio 00168, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)

Milan, Lombardy 20122, Italy

ASST Fatebenefratelli Sacco ( Site 0434)

Milan, Lombardy 20154, Italy

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

Padova, Veneto 35128, Italy

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

Parma, 43126, Italy

Fukuoka Children's Hospital ( Site 0452)

Fukuoka, Fukuoka 813-0017, Japan

Iizuka Hospital ( Site 0457)

Iizuka, Fukuoka 820-8505, Japan

Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)

Kitakyushu-shi, Fukuoka 806-8501, Japan

Maebashi Red Cross Hospital ( Site 0451)

Maebashi, Gunma 371-0811, Japan

Ibaraki Children's Hospital ( Site 0458)

Mito, Ibaraki 311-4145, Japan

Nihon University Itabashi Hospital ( Site 0453)

Itabashiku, Tokyo 173-8610, Japan

Shizuoka Saiseikai General Hospital ( Site 0456)

Shizuoka, 422-8527, Japan

National Center for Child Health and Development ( Site 0455)

Tokyo, 157-8535, Japan

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

Kota Bharu, Kelantan 15586, Malaysia

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

Lembah Pantai, Kuala Lumpur 59100, Malaysia

Hospital Pulau Pinang ( Site 0482)

George Town, Pulau Pinang 10450, Malaysia

Sabah Women and Children Hospital ( Site 0478)

Kota Kinabalu, Sabah 88996, Malaysia

Hospital Sibu ( Site 0476)

Sibu, Sarawak 96000, Malaysia

Hospital Tunku Azizah-Paediatric ( Site 0481)

Kuala Lumpur, 50300, Malaysia

Morales Vargas Centro de Investigacion ( Site 0509)

León, Guanajuato 37000, Mexico

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

Guadalajara, Jalisco 44650, Mexico

Instituto Nacional de Pediatria ( Site 0506)

Mexico City, Mexico City 04530, Mexico

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

Durango, 34000, Mexico

Oaxaca Site Management Organization ( Site 0504)

Oaxaca City, 68000, Mexico

ONCOLOGICO POTOSINO, S.C. ( Site 0505)

San Luis Potosí City, 78209, Mexico

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

Newtown, Wellington Region 6021, New Zealand

Middlemore Clinical Trials ( Site 0526)

Auckland, 2025, New Zealand

Oslo Universitetssykehus Ullevål ( Site 0551)

Oslo, 0450, Norway

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

Jesús María, Lima 15072, Peru

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

Lima, 15001, Peru

UPR Medical Sciences Campus-Pediatrics ( Site 0626)

San Juan, 00935, Puerto Rico

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

Singapore, South West 229899, Singapore

Reimed ( Site 0706)

Boksburg, Gauteng 1459, South Africa

Chris Hani Baragwanath Academic Hospital ( Site 0701)

Soweto, Gauteng 2013, South Africa

King Edward VIII Hospital ( Site 0704)

Durban, KwaZulu-Natal 4001, South Africa

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

Cape Town, Western Cape 7500, South Africa

Panorama Medical Centre ( Site 0702)

Cape Town, Western Cape 7500, South Africa

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

Cape Town, Western Cape 7700, South Africa

2 Military Hospital ( Site 0708)

Cape Town, Western Cape 7824, South Africa

Hospital Germans Trias i Pujol ( Site 0738)

Badalona, Barcelona 08916, Spain

Hospital Sant Joan de Déu ( Site 0730)

Esplugues de Llobregat, Barcelona 08950, Spain

Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)

Sant Cugat del Vallès, Barcelona 08195, Spain

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

Santiago de Compostela, La Coruna 15706, Spain

Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)

Boadilla del Monte, Madrid 28660, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)

Pozuelo de Alarcón, Madrid 28223, Spain

Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728)

Madrid, Madrid, Comunidad de 28041, Spain

Hospital Universitario Central de Asturias ( Site 0740)

Oviedo, Principality of Asturias 33011, Spain

Hospital Universitario La Paz ( Site 0726)

Madrid, 28046, Spain

Grupo Pediatrico Uncibay ( Site 0734)

Málaga, 29015, Spain

Taichung Veterans General Hospital ( Site 0754)

Taichung, 407, Taiwan

National Taiwan University Hospital ( Site 0751)

Taipei, 10002, Taiwan

Mackay Memorial Hospital-Pediatrics ( Site 0753)

Taipei, 10449, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0752)

Taoyuan, 33305, Taiwan

Chulalongkorn University-Pediatrics ( Site 0777)

Bangkok, Bangkok 10330, Thailand

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

Bangkok, Bangkok 10700, Thailand

Songklanagarind hospital-Department of Pediatrics ( Site 0776)

Hat Yai, Changwat Songkhla 90110, Thailand

cukurova universty ( Site 0805)

Sarçam, Adana 01030, Turkey (Türkiye)

Ankara University Hospital Cebeci ( Site 0801)

Ankara, 06100, Turkey (Türkiye)

Gazi Universitesi ( Site 0806)

Ankara, 06560, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi. ( Site 0807)

Ankara, 06800, Turkey (Türkiye)

Erciyes University Medical Faculty-pediatric infection ( Site 0804)

Kayseri, 38039, Turkey (Türkiye)

Whipps Cross University Hospital ( Site 0846)

London, England E11 1NR, United Kingdom

St. George's Hospital ( Site 0845)

London, England SW17 0RE, United Kingdom

Queen Elizabeth University Hospital ( Site 0842)

Glasgow, Glasgow City G51 4TF, United Kingdom

Evelina London Children's Hospital ( Site 0829)

London, Great Britain SE1 7EH, United Kingdom

Southampton General Hospital ( Site 0826)

Southampton, Hampshire SO16 0YD, United Kingdom

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

London, London, City of E1 1BB, United Kingdom

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

Oxford, Oxfordshire OX3 9DU, United Kingdom

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

Liverpool, L12 2AP, United Kingdom