Clesrovimab (MK-1654) in lattanti e bambini ad aumentato rischio di malattia da virus respiratorio sinciziale grave (RSV) (MK-1654-007) (SMART)
17 aprile 2026 aggiornato da: Merck Sharp & Dohme LLC
Uno studio di fase 3, multicentrico, randomizzato, parzialmente in cieco, controllato da Palivizumab per valutare la sicurezza, l'efficacia e la farmacocinetica dell'MK-1654 in neonati e bambini ad aumentato rischio di grave malattia da VRS
Questo studio mira a valutare la sicurezza e la tollerabilità di clesrovimab rispetto a palivizumab come valutato dalla percentuale di partecipanti che hanno manifestato eventi avversi (AE).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1003
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Queensland
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Brisbane, Queensland, Australia, 4101
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- Canadian Center for Vaccinology ( Site 0179)
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine ( Site 0178)
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Cechia, 708 52
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
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Praha 4
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Prague, Praha 4, Cechia, 14700
- Institute for the Care of Mother and Child ( Site 0251)
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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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Antioquia
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Medellín, Antioquia, Colombia, 050010
- Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
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Medellín, Antioquia, Colombia, 50036
- Clínica Universitaria Bolivariana ( Site 0227)
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Atlántico
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Barranquilla, Atlántico, Colombia, 08001
- Ciensalud Ips S A S ( Site 0235)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 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, Colombia, 760042
- Clínica Imbanaco S.A.S ( Site 0229)
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Keski-Pohjanmaa
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Kokkola, Keski-Pohjanmaa, Finlandia, 67100
- FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finlandia, 90220
- FVR, Oulun rokotetutkimusklinikka ( Site 0303)
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Pirkanmaa
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Tampere, Pirkanmaa, Finlandia, 33100
- FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
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South Ostrobothnia
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Seinäjoki, South Ostrobothnia, Finlandia, 60100
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
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Southwest Finland
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Turku, Southwest Finland, Finlandia, 20520
- FVR, Turun rokotetutkimusklinikka ( Site 0302)
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Uusimaa
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Helsinki, Uusimaa, Finlandia, 00290
- MeVac - Meilahti Vaccine Research Center ( Site 0306)
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Aquitaine
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Bordeaux, Aquitaine, Francia, 33076
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
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Calvados
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Caen, Calvados, Francia, 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, Francia, 78157
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Germania, 79106
- Universitaetsklinikum Freiburg ( Site 0365)
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Heidelberg, Baden-Wurttemberg, Germania, 69120
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
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Bavaria
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Munich, Bavaria, Germania, 80337
- Dr. von Haunersches Kinderspital ( Site 0358)
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Munich, Bavaria, Germania, 81545
- München Klinik Harlaching ( Site 0351)
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Lower Saxony
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Hanover, Lower Saxony, Germania, 30625
- Medizinische Hochschule Hannover ( Site 0364)
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North Rhine-Westphalia
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Oberhausen, North Rhine-Westphalia, Germania, 46145
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
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Saxony
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Dresden, Saxony, Germania, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
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Leipzig, Saxony, Germania, 04103
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germania, 23538
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
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Shizuoka, Giappone, 422-8527
- Shizuoka Saiseikai General Hospital ( Site 0456)
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Tokyo, Giappone, 157-8535
- National Center for Child Health and Development ( Site 0455)
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Fukuoka
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Fukuoka, Fukuoka, Giappone, 813-0017
- Fukuoka Children's Hospital ( Site 0452)
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Iizuka, Fukuoka, Giappone, 820-8505
- Iizuka Hospital ( Site 0457)
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Kitakyushu-shi, Fukuoka, Giappone, 806-8501
- Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
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Gunma
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Maebashi, Gunma, Giappone, 371-0811
- Maebashi Red Cross Hospital ( Site 0451)
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Ibaraki
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Mito, Ibaraki, Giappone, 311-4145
- Ibaraki Children's Hospital ( Site 0458)
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Tokyo
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Itabashiku, Tokyo, Giappone, 173-8610
- Nihon University Itabashi Hospital ( Site 0453)
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Attica
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Athens, Attica, Grecia, 115 27
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
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Athens, Attica, Grecia, 115 27
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
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Chaïdári, Attica, Grecia, 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, Grecia, 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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Parma, Italia, 43126
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
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Lazio
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Rome, Lazio, Italia, 00165
- Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
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Rome, Lazio, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
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Lombardy
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Milan, Lombardy, Italia, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
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Milan, Lombardy, Italia, 20154
- ASST Fatebenefratelli Sacco ( Site 0434)
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Veneto
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Padova, Veneto, Italia, 35128
- Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
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Kuala Lumpur, Malaysia, 50300
- Hospital Tunku Azizah-Paediatric ( Site 0481)
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 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, Malaysia, 59100
- University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10450
- Hospital Pulau Pinang ( Site 0482)
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Sabah
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Kota Kinabalu, Sabah, Malaysia, 88996
- Sabah Women and Children Hospital ( Site 0478)
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Sarawak
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Sibu, Sarawak, Malaysia, 96000
- Hospital Sibu ( Site 0476)
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Durango, Messico, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
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Oaxaca City, Messico, 68000
- Oaxaca Site Management Organization ( Site 0504)
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San Luis Potosí City, Messico, 78209
- ONCOLOGICO POTOSINO, S.C. ( Site 0505)
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Guanajuato
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León, Guanajuato, Messico, 37000
- Morales Vargas Centro de Investigacion ( Site 0509)
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Jalisco
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Guadalajara, Jalisco, Messico, 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, Messico, 04530
- Instituto Nacional de Pediatria ( Site 0506)
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Oslo, Norvegia, 0450
- Oslo Universitetssykehus Ullevål ( Site 0551)
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Auckland, Nuova Zelanda, 2025
- Middlemore Clinical Trials ( Site 0526)
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Wellington Region
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Newtown, Wellington Region, Nuova Zelanda, 6021
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
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Lima, Perù, 15001
- HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
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Lima
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Jesús María, Lima, Perù, 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, Regno Unito, L12 2AP
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
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England
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London, England, Regno Unito, E11 1NR
- Whipps Cross University Hospital ( Site 0846)
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London, England, Regno Unito, SW17 0RE
- St. George's Hospital ( Site 0845)
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Glasgow City
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Glasgow, Glasgow City, Regno Unito, G51 4TF
- Queen Elizabeth University Hospital ( Site 0842)
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Great Britain
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London, Great Britain, Regno Unito, SE1 7EH
- Evelina London Children's Hospital ( Site 0829)
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Hampshire
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Southampton, Hampshire, Regno Unito, SO16 0YD
- Southampton General Hospital ( Site 0826)
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London, City of
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London, London, City of, Regno Unito, E1 1BB
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
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Oxfordshire
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Oxford, Oxfordshire, Regno Unito, OX3 9DU
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
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South West
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Singapore, South West, Singapore, 229899
- KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
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Madrid, Spagna, 28046
- Hospital Universitario La Paz ( Site 0726)
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Málaga, Spagna, 29015
- Grupo Pediatrico Uncibay ( Site 0734)
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Barcelona
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Badalona, Barcelona, Spagna, 08916
- Hospital Germans Trias i Pujol ( Site 0738)
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Esplugues de Llobregat, Barcelona, Spagna, 08950
- Hospital Sant Joan de Déu ( Site 0730)
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Sant Cugat del Vallès, Barcelona, Spagna, 08195
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
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La Coruna
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Santiago de Compostela, La Coruna, Spagna, 15706
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
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Madrid
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Boadilla del Monte, Madrid, Spagna, 28660
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
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Pozuelo de Alarcón, Madrid, Spagna, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spagna, 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, Spagna, 33011
- Hospital Universitario Central de Asturias ( Site 0740)
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California
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Long Beach, California, Stati Uniti, 90806
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
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Orange, California, Stati Uniti, 92868
- Children's Hospital of Orange County ( Site 0047)
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Children's Hospital Colorado ( Site 0011)
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20010
- Children's National Medical Center ( Site 0020)
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Florida
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Orlando, Florida, Stati Uniti, 32827
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)
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Orlando, Florida, Stati Uniti, 32806
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
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Tampa, Florida, Stati Uniti, 33606
- University of South Florida-Department of Pediatrics ( Site 0045)
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Georgia
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Atlanta, Georgia, Stati Uniti, 30310
- Morehouse School Of Medicine ( Site 0049)
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83404
- Clinical Research Prime ( Site 0046)
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536
- University of Kentucky HealthCare - Turfland ( Site 0044)
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Our Lady of the Lake Children's Hospital ( Site 0031)
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University School of Medicine ( Site 0010)
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 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, Stati Uniti, 08901
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)
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New York
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Mineola, New York, Stati Uniti, 11501
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
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Rochester, New York, Stati Uniti, 14642
- University of Rochester Medical Center ( Site 0017)
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- The University of North Carolina at Chapel Hill ( Site 0035)
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Durham, North Carolina, Stati Uniti, 27710
- Duke University ( Site 0021)
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Ohio
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Dayton, Ohio, Stati Uniti, 45449
- Dayton Children's Hospital ( Site 0053)
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29607
- Tribe Clinical Research, LLC ( Site 0002)
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Texas
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Corpus Christi, Texas, Stati Uniti, 78411
- Driscoll Children's Hospital ( Site 0025)
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Edinburg, Texas, Stati Uniti, 78539
- DHR Health Institute for Research and Development ( Site 0029)
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San Antonio, Texas, Stati Uniti, 78207
- Christus Children's-Clinical Research Center ( Site 0038)
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San Antonio, Texas, Stati Uniti, 78229
- University Hospital-Pediatrics ( Site 0019)
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San Antonio, Texas, Stati Uniti, 78249
- Road Runner Research, Ltd ( Site 0052)
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Utah
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Salt Lake City, Utah, Stati Uniti, 84113
- Intermountain - Primary Children's Hospital ( Site 0026)
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Washington
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Spokane, Washington, Stati Uniti, 99202
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
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Spokane, Washington, Stati Uniti, 99204
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
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Tacoma, Washington, Stati Uniti, 98405
- MultiCare Health System-Baker Center ( Site 0036)
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Gauteng
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Boksburg, Gauteng, Sud Africa, 1459
- Reimed ( Site 0706)
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Soweto, Gauteng, Sud Africa, 2013
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sud Africa, 4001
- King Edward VIII Hospital ( Site 0704)
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Western Cape
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Cape Town, Western Cape, Sud Africa, 7500
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
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Cape Town, Western Cape, Sud Africa, 7500
- Panorama Medical Centre ( Site 0702)
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Cape Town, Western Cape, Sud Africa, 7700
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
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Cape Town, Western Cape, Sud Africa, 7824
- 2 Military Hospital ( Site 0708)
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Bangkok
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Bangkok, Bangkok, Tailandia, 10330
- Chulalongkorn University-Pediatrics ( Site 0777)
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Bangkok, Bangkok, Tailandia, 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, Tailandia, 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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Ankara, Turchia (Türkiye), 06100
- Ankara University Hospital Cebeci ( Site 0801)
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Ankara, Turchia (Türkiye), 06560
- Gazi Universitesi ( Site 0806)
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)
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Kayseri, Turchia (Türkiye), 38039
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)
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Adana
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Sarçam, Adana, Turchia (Türkiye), 01030
- cukurova universty ( Site 0805)
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Budapest, Ungheria, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
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Budapest, Ungheria, 1082
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
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Budapest, Ungheria, 1096
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
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Debrecen, Ungheria, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)
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Borsod-Abauj Zemplen county
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Miskolc, Borsod-Abauj Zemplen county, Ungheria, 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, Ungheria
- Bajai Szent Rókus Kórház ( Site 0386)
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Kecskemét, Bács-Kiskun county, Ungheria, 6000
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungheria, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 1 anno (Bambino)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- I partecipanti ad aumentato rischio di grave infezione da RSV hanno raccomandato di ricevere palivizumab in conformità con le linee guida nazionali o locali o le raccomandazioni della società professionale.
- È disponibile per completare il periodo di follow-up.
Criteri di esclusione:
- Richiede ventilazione meccanica al momento dell'arruolamento.
- Ha un'aspettativa di vita
- Ha una disfunzione epatica o renale nota o un disturbo convulsivo cronico.
- È ricoverato in ospedale al momento della randomizzazione a meno che non sia prevista la dimissione entro 7 giorni dalla randomizzazione.
- Ha una grave immunodeficienza o è gravemente immunocompromesso.
- Ha nota ipersensibilità a qualsiasi componente di clesrovimab o palivizumab.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Clerovimab
I partecipanti riceveranno iniezioni intramuscolari (IM) di clesrovimab e placebo
|
Iniezione IM
Altri nomi:
Iniezione IM
|
|
Comparatore attivo: Palivizumab
I partecipanti riceveranno iniezioni IM.
|
Iniezione IM
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Lasso di tempo: 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 injection-site AEs included erythema, pain, and swelling.
The number of participants with solicited injection-site 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 Solicited Daily Body Temperatures With Fever in RSV Season 1
Lasso di tempo: Up to 5 days after each dose in RSV Season 1 (Up to ~33 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 1 is reported.
|
Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 novembre 2021
Completamento primario (Effettivo)
28 aprile 2025
Completamento dello studio (Effettivo)
1 agosto 2025
Date di iscrizione allo studio
Primo inviato
22 giugno 2021
Primo inviato che soddisfa i criteri di controllo qualità
22 giugno 2021
Primo Inserito (Effettivo)
24 giugno 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Infezioni da pneumovirus
- Infezioni da Paramyxoviridae
- Infezioni da Mononegavirus
- Infezioni da virus respiratorio sinciziale
- Aminoacidi, peptidi e proteine
- Proteine
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Palivizumab
- MK-1654
Altri numeri di identificazione dello studio
- 1654-007
- MK-1654-007 (Altro identificatore: MSD)
- jRCT2031210664 (Identificatore di registro: jRCT)
- 2020-005996-11 (Numero EudraCT)
- U1111-1278-0093 (Identificatore di registro: UTN)
- 2022-500752-39-00 (Identificatore di registro: EU CT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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