Clesrovimab (MK-1654) em bebês e crianças com risco aumentado para doença grave do vírus sincicial respiratório (VSR) (MK-1654-007) (SMART)
17 de abril de 2026 atualizado por: Merck Sharp & Dohme LLC
Um estudo de fase 3, multicêntrico, randomizado, parcialmente cego, controlado por palivizumabe para avaliar a segurança, eficácia e farmacocinética do MK-1654 em bebês e crianças com risco aumentado de doença grave por VSR
Este estudo tem como objetivo avaliar a segurança e a tolerabilidade do clesrovimab em comparação com o palivizumab, conforme avaliado pela proporção de participantes que apresentaram eventos adversos (EAs).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1003
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Alemanha, 79106
- Universitaetsklinikum Freiburg ( Site 0365)
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Heidelberg, Baden-Wurttemberg, Alemanha, 69120
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
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Bavaria
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Munich, Bavaria, Alemanha, 80337
- Dr. von Haunersches Kinderspital ( Site 0358)
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Munich, Bavaria, Alemanha, 81545
- München Klinik Harlaching ( Site 0351)
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Lower Saxony
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Hanover, Lower Saxony, Alemanha, 30625
- Medizinische Hochschule Hannover ( Site 0364)
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North Rhine-Westphalia
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Oberhausen, North Rhine-Westphalia, Alemanha, 46145
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
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Saxony
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Dresden, Saxony, Alemanha, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
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Leipzig, Saxony, Alemanha, 04103
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Alemanha, 23538
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
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Queensland
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Brisbane, Queensland, Austrália, 4101
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)
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Western Australia
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Nedlands, Western Australia, Austrália, 6009
- Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
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Alberta
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Calgary, Alberta, Canadá, T3B 6A8
- Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3K 6R8
- Canadian Center for Vaccinology ( Site 0179)
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- CHU Sainte-Justine ( Site 0178)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8320325
- Clínica Alemana de Santiago-Neonatology department ( Site 0207)
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Santiago, Region M. de Santiago, Chile, 8380418
- Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
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Santiago, Region M. de Santiago, Chile, 8880465
- Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
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South West
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Singapore, South West, Cingapura, 229899
- KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
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Antioquia
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Medellín, Antioquia, Colômbia, 050010
- Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
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Medellín, Antioquia, Colômbia, 50036
- Clínica Universitaria Bolivariana ( Site 0227)
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Atlántico
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Barranquilla, Atlántico, Colômbia, 08001
- Ciensalud Ips S A S ( Site 0235)
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Bogota D.C.
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Bogotá, Bogota D.C., Colômbia, 111411
- Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colômbia, 760042
- Clínica Imbanaco S.A.S ( Site 0229)
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Madrid, Espanha, 28046
- Hospital Universitario La Paz ( Site 0726)
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Málaga, Espanha, 29015
- Grupo Pediatrico Uncibay ( Site 0734)
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Barcelona
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Badalona, Barcelona, Espanha, 08916
- Hospital Germans Trias i Pujol ( Site 0738)
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Esplugues de Llobregat, Barcelona, Espanha, 08950
- Hospital Sant Joan de Déu ( Site 0730)
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Sant Cugat del Vallès, Barcelona, Espanha, 08195
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
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La Coruna
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Santiago de Compostela, La Coruna, Espanha, 15706
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
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Madrid
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Boadilla del Monte, Madrid, Espanha, 28660
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
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Pozuelo de Alarcón, Madrid, Espanha, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espanha, 28041
- Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728)
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Principality of Asturias
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Oviedo, Principality of Asturias, Espanha, 33011
- Hospital Universitario Central de Asturias ( Site 0740)
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California
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Long Beach, California, Estados Unidos, 90806
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County ( Site 0047)
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Colorado ( Site 0011)
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- Children's National Medical Center ( Site 0020)
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Florida
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Orlando, Florida, Estados Unidos, 32827
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)
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Orlando, Florida, Estados Unidos, 32806
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida-Department of Pediatrics ( Site 0045)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30310
- Morehouse School Of Medicine ( Site 0049)
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Clinical Research Prime ( Site 0046)
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky HealthCare - Turfland ( Site 0044)
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Our Lady of the Lake Children's Hospital ( Site 0031)
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University School of Medicine ( Site 0010)
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55454
- M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037)
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)
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New York
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Mineola, New York, Estados Unidos, 11501
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center ( Site 0017)
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- The University of North Carolina at Chapel Hill ( Site 0035)
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Durham, North Carolina, Estados Unidos, 27710
- Duke University ( Site 0021)
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Ohio
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Dayton, Ohio, Estados Unidos, 45449
- Dayton Children's Hospital ( Site 0053)
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Tribe Clinical Research, LLC ( Site 0002)
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Texas
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital ( Site 0025)
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Edinburg, Texas, Estados Unidos, 78539
- DHR Health Institute for Research and Development ( Site 0029)
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San Antonio, Texas, Estados Unidos, 78207
- Christus Children's-Clinical Research Center ( Site 0038)
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San Antonio, Texas, Estados Unidos, 78229
- University Hospital-Pediatrics ( Site 0019)
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San Antonio, Texas, Estados Unidos, 78249
- Road Runner Research, Ltd ( Site 0052)
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113
- Intermountain - Primary Children's Hospital ( Site 0026)
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Washington
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Spokane, Washington, Estados Unidos, 99202
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
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Spokane, Washington, Estados Unidos, 99204
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
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Tacoma, Washington, Estados Unidos, 98405
- MultiCare Health System-Baker Center ( Site 0036)
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Keski-Pohjanmaa
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Kokkola, Keski-Pohjanmaa, Finlândia, 67100
- FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finlândia, 90220
- FVR, Oulun rokotetutkimusklinikka ( Site 0303)
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Pirkanmaa
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Tampere, Pirkanmaa, Finlândia, 33100
- FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
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South Ostrobothnia
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Seinäjoki, South Ostrobothnia, Finlândia, 60100
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
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Southwest Finland
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Turku, Southwest Finland, Finlândia, 20520
- FVR, Turun rokotetutkimusklinikka ( Site 0302)
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Uusimaa
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Helsinki, Uusimaa, Finlândia, 00290
- MeVac - Meilahti Vaccine Research Center ( Site 0306)
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Aquitaine
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Bordeaux, Aquitaine, França, 33076
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
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Calvados
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Caen, Calvados, França, 14033
- Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330)
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Yvelines
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Le Chesnay, Yvelines, França, 78157
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
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Attica
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Athens, Attica, Grécia, 115 27
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
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Athens, Attica, Grécia, 115 27
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
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Chaïdári, Attica, Grécia, 124 62
- ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
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Central Macedonia
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Thessaloniki, Central Macedonia, Grécia, 54642
- Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
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Shatin, Hong Kong
- Prince of Wales Hospital ( Site 0926)
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Tuenmen, Hong Kong, 999077
- Tuen Mun Hospital ( Site 0927)
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Budapest, Hungria, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
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Budapest, Hungria, 1082
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
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Budapest, Hungria, 1096
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
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Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)
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Borsod-Abauj Zemplen county
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Miskolc, Borsod-Abauj Zemplen county, Hungria, 3526
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388)
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Bács-Kiskun county
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Baja, Bács-Kiskun county, Hungria
- Bajai Szent Rókus Kórház ( Site 0386)
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Kecskemét, Bács-Kiskun county, Hungria, 6000
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungria, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
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Parma, Itália, 43126
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
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Lazio
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Rome, Lazio, Itália, 00165
- Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
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Rome, Lazio, Itália, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
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Lombardy
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Milan, Lombardy, Itália, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
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Milan, Lombardy, Itália, 20154
- ASST Fatebenefratelli Sacco ( Site 0434)
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Veneto
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Padova, Veneto, Itália, 35128
- Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
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Shizuoka, Japão, 422-8527
- Shizuoka Saiseikai General Hospital ( Site 0456)
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Tokyo, Japão, 157-8535
- National Center for Child Health and Development ( Site 0455)
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Fukuoka
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Fukuoka, Fukuoka, Japão, 813-0017
- Fukuoka Children's Hospital ( Site 0452)
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Iizuka, Fukuoka, Japão, 820-8505
- Iizuka Hospital ( Site 0457)
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Kitakyushu-shi, Fukuoka, Japão, 806-8501
- Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
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Gunma
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Maebashi, Gunma, Japão, 371-0811
- Maebashi Red Cross Hospital ( Site 0451)
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Ibaraki
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Mito, Ibaraki, Japão, 311-4145
- Ibaraki Children's Hospital ( Site 0458)
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Tokyo
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Itabashiku, Tokyo, Japão, 173-8610
- Nihon University Itabashi Hospital ( Site 0453)
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Kuala Lumpur, Malásia, 50300
- Hospital Tunku Azizah-Paediatric ( Site 0481)
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Kelantan
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Kota Bharu, Kelantan, Malásia, 15586
- Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
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Pulau Pinang
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George Town, Pulau Pinang, Malásia, 10450
- Hospital Pulau Pinang ( Site 0482)
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Sabah
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Kota Kinabalu, Sabah, Malásia, 88996
- Sabah Women and Children Hospital ( Site 0478)
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Sarawak
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Sibu, Sarawak, Malásia, 96000
- Hospital Sibu ( Site 0476)
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Durango, México, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
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Oaxaca City, México, 68000
- Oaxaca Site Management Organization ( Site 0504)
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San Luis Potosí City, México, 78209
- ONCOLOGICO POTOSINO, S.C. ( Site 0505)
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Guanajuato
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León, Guanajuato, México, 37000
- Morales Vargas Centro de Investigacion ( Site 0509)
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Jalisco
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Guadalajara, Jalisco, México, 44650
- Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
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Mexico City
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Mexico City, Mexico City, México, 04530
- Instituto Nacional de Pediatria ( Site 0506)
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Oslo, Noruega, 0450
- Oslo Universitetssykehus Ullevål ( Site 0551)
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Auckland, Nova Zelândia, 2025
- Middlemore Clinical Trials ( Site 0526)
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Wellington Region
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Newtown, Wellington Region, Nova Zelândia, 6021
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
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Lima, Peru, 15001
- HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
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Lima
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Jesús María, Lima, Peru, 15072
- Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
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San Juan, Porto Rico, 00935
- UPR Medical Sciences Campus-Pediatrics ( Site 0626)
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Liverpool, Reino Unido, L12 2AP
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
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England
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London, England, Reino Unido, E11 1NR
- Whipps Cross University Hospital ( Site 0846)
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London, England, Reino Unido, SW17 0RE
- St. George's Hospital ( Site 0845)
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Glasgow City
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Glasgow, Glasgow City, Reino Unido, G51 4TF
- Queen Elizabeth University Hospital ( Site 0842)
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Great Britain
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London, Great Britain, Reino Unido, SE1 7EH
- Evelina London Children's Hospital ( Site 0829)
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Hampshire
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Southampton, Hampshire, Reino Unido, SO16 0YD
- Southampton General Hospital ( Site 0826)
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London, City of
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London, London, City of, Reino Unido, E1 1BB
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
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Oxfordshire
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Oxford, Oxfordshire, Reino Unido, OX3 9DU
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
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Bangkok
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Bangkok, Bangkok, Tailândia, 10330
- Chulalongkorn University-Pediatrics ( Site 0777)
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Bangkok, Bangkok, Tailândia, 10700
- Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Tailândia, 90110
- Songklanagarind hospital-Department of Pediatrics ( Site 0776)
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital ( Site 0754)
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital-Pediatrics ( Site 0753)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 0751)
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Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Tcheca, 708 52
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
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Praha 4
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Prague, Praha 4, Tcheca, 14700
- Institute for the Care of Mother and Child ( Site 0251)
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Ankara, Turquia (Türkiye), 06100
- Ankara University Hospital Cebeci ( Site 0801)
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Ankara, Turquia (Türkiye), 06560
- Gazi Universitesi ( Site 0806)
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Ankara, Turquia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)
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Kayseri, Turquia (Türkiye), 38039
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)
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Adana
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Sarçam, Adana, Turquia (Türkiye), 01030
- cukurova universty ( Site 0805)
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Gauteng
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Boksburg, Gauteng, África do Sul, 1459
- Reimed ( Site 0706)
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Soweto, Gauteng, África do Sul, 2013
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, África do Sul, 4001
- King Edward VIII Hospital ( Site 0704)
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Western Cape
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Cape Town, Western Cape, África do Sul, 7500
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
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Cape Town, Western Cape, África do Sul, 7500
- Panorama Medical Centre ( Site 0702)
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Cape Town, Western Cape, África do Sul, 7700
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
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Cape Town, Western Cape, África do Sul, 7824
- 2 Military Hospital ( Site 0708)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 1 ano (Filho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Os participantes com risco aumentado de infecção grave por RSV recomendaram receber palivizumabe de acordo com as diretrizes nacionais ou locais ou recomendações da sociedade profissional.
- Está disponível para completar o período de acompanhamento.
Critério de exclusão:
- Requer ventilação mecânica no momento da inscrição.
- Tem uma expectativa de vida
- Tem disfunção hepática ou renal conhecida ou distúrbio convulsivo crônico.
- Está hospitalizado no momento da randomização, a menos que a alta seja esperada dentro de 7 dias após a randomização.
- Tem imunodeficiência grave ou está gravemente imunocomprometido.
- Tem hipersensibilidade conhecida a qualquer componente de clesrovimab ou palivizumab.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Clesrovimabe
Os participantes receberão injeções intramusculares (IM) de clesrovimab e placebo
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Injeção IM
Outros nomes:
Injeção IM
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Comparador Ativo: Palivizumabe
Os participantes receberão injeções IM.
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Injeção IM
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Prazo: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited injection-site AEs included erythema, pain, and swelling.
The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
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Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1
Prazo: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F.
The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.
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Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
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|
Number of Participants With Solicited Systemic AEs in RSV Season 1
Prazo: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited systemic AEs included decreased appetite, irritability, and somnolence.
The number of participants with solicited systemic AEs in RSV Season 1 is reported.
|
Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
|
|
Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1
Prazo: Up to 42 days in RSV Season 1
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.
|
Up to 42 days in RSV Season 1
|
|
Number of Participants With Rash AESI in RSV Season 1
Prazo: Up to 42 days in RSV Season 1
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Rash AESI included urticaria and drug eruption.
The number of participants with rash AESI in RSV Season 1 is reported.
|
Up to 42 days in RSV Season 1
|
|
Number of Participants With Nonserious AEs in RSV Season 1
Prazo: Up to 42 days in RSV Season 1
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with nonserious AEs in RSV Season 1 is reported.
|
Up to 42 days in RSV Season 1
|
|
Number of Participants With Serious AEs (SAEs) Through the Duration of Participation in RSV Season 1
Prazo: Up to 365 days in RSV Season 1
|
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
The number of participants with SAEs in RSV Season 1 is reported.
|
Up to 365 days in RSV Season 1
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
Prazo: Up to 150 days in RSV Season 1
|
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal (NP) sample.
The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1.
For each participant, only the first occurrence of the case is counted for the analysis.
|
Up to 150 days in RSV Season 1
|
|
Number of Cases of RSV-associated Hospitalization in RSV Season 1
Prazo: Up to 150 days in RSV Season 1
|
RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR NP sample.
The number of cases of RSV-associated hospitalization in RSV Season 1 is reported.
For each participant, only the first occurrence of the case is counted for the analysis.
|
Up to 150 days in RSV Season 1
|
|
Number of Participants With Solicited Injection-site AEs in RSV Season 2
Prazo: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited injection-site AEs included erythema, pain, and swelling.
The number of participants with solicited injection-site AEs in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2
Prazo: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F.
The number of participants with solicited daily body temperature of fever in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 2
Prazo: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Solicited systemic AEs included decreased appetite, irritability, and somnolence.
The number of participants with solicited systemic AEs in RSV Season 2 is reported.
|
Up to 5 days postdose in RSV Season 2 (Up to ~400 days)
|
|
Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2
Prazo: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 is reported.
|
Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With Rash AESI in RSV Season 2
Prazo: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Rash AESI included urticaria and drug eruption.
The number of participants with rash AESI in RSV Season 2 is reported.
|
Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With Nonserious AEs in RSV Season 2
Prazo: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants with nonserious AEs in RSV Season 2 is reported.
|
Up to 42 days postdose in RSV Season 2 (Up to ~440 days)
|
|
Number of Participants With SAEs in RSV Season 2
Prazo: Up 180 days postdose in RSV Season 2 (Up to ~575 days)
|
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
The number of participants with SAEs in RSV Season 2 is reported.
|
Up 180 days postdose in RSV Season 2 (Up to ~575 days)
|
|
Concentration of Clesrovimab in RSV Season 1
Prazo: At Day 7, Day 150, and Day 240 in RSV Season 1
|
Blood samples were collected to determine the serum concentration of clesrovimab at Days 7, 150, and 240 in RSV Season 1.
|
At Day 7, Day 150, and Day 240 in RSV Season 1
|
|
Concentration of Clesrovimab in RSV Season 2
Prazo: At Day 7 and Day 150 postdose in RSV Season 2
|
Blood samples were collected to determine the serum concentration of clesrovimab at Days 7 and 150 in RSV Season 2. RSV Season 2 began 246-393 days after RSV Season 1 dose 1.
|
At Day 7 and Day 150 postdose in RSV Season 2
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de novembro de 2021
Conclusão Primária (Real)
28 de abril de 2025
Conclusão do estudo (Real)
1 de agosto de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
22 de junho de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2021
Primeira postagem (Real)
24 de junho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Infecções por Pneumovírus
- Infecções por Paramyxoviridae
- Infecções por Mononegavirales
- Infecções por Vírus Sincicial Respiratório
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Palivizumabe
- MK-1654
Outros números de identificação do estudo
- 1654-007
- MK-1654-007 (Outro identificador: MSD)
- jRCT2031210664 (Identificador de registro: jRCT)
- 2020-005996-11 (Número EudraCT)
- U1111-1278-0093 (Identificador de registro: UTN)
- 2022-500752-39-00 (Identificador de registro: EU CT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .