Clesrovimab (MK-1654) bij zuigelingen en kinderen met een verhoogd risico op de ziekte van ernstig respiratoir syncytieel virus (RSV) (MK-1654-007) (SMART)
17 april 2026 bijgewerkt door: Merck Sharp & Dohme LLC
Een multicenter, gerandomiseerd, gedeeltelijk geblindeerd, palivizumab-gecontroleerd fase 3-onderzoek ter evaluatie van de veiligheid, werkzaamheid en farmacokinetiek van MK-1654 bij zuigelingen en kinderen met een verhoogd risico op ernstige RSV-ziekte
Deze studie heeft tot doel de veiligheid en verdraagbaarheid van clesrovimab te evalueren in vergelijking met palivizumab, zoals beoordeeld aan de hand van het aantal deelnemers dat bijwerkingen ervaart.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1003
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Queensland
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Brisbane, Queensland, Australië, 4101
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)
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Western Australia
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Nedlands, Western Australia, Australië, 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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Region M. de Santiago
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Santiago, Region M. de Santiago, Chili, 8320325
- Clínica Alemana de Santiago-Neonatology department ( Site 0207)
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Santiago, Region M. de Santiago, Chili, 8380418
- Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
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Santiago, Region M. de Santiago, Chili, 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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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Duitsland, 79106
- Universitaetsklinikum Freiburg ( Site 0365)
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Heidelberg, Baden-Wurttemberg, Duitsland, 69120
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
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Bavaria
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Munich, Bavaria, Duitsland, 80337
- Dr. von Haunersches Kinderspital ( Site 0358)
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Munich, Bavaria, Duitsland, 81545
- München Klinik Harlaching ( Site 0351)
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Lower Saxony
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Hanover, Lower Saxony, Duitsland, 30625
- Medizinische Hochschule Hannover ( Site 0364)
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North Rhine-Westphalia
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Oberhausen, North Rhine-Westphalia, Duitsland, 46145
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
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Saxony
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Dresden, Saxony, Duitsland, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
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Leipzig, Saxony, Duitsland, 04103
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Duitsland, 23538
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
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Keski-Pohjanmaa
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Kokkola, Keski-Pohjanmaa, Finland, 67100
- FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finland, 90220
- FVR, Oulun rokotetutkimusklinikka ( Site 0303)
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33100
- FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
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South Ostrobothnia
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Seinäjoki, South Ostrobothnia, Finland, 60100
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
- FVR, Turun rokotetutkimusklinikka ( Site 0302)
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Uusimaa
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Helsinki, Uusimaa, Finland, 00290
- MeVac - Meilahti Vaccine Research Center ( Site 0306)
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Aquitaine
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Bordeaux, Aquitaine, Frankrijk, 33076
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
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Calvados
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Caen, Calvados, Frankrijk, 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, Frankrijk, 78157
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
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Attica
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Athens, Attica, Griekenland, 115 27
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
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Athens, Attica, Griekenland, 115 27
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
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Chaïdári, Attica, Griekenland, 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, Griekenland, 54642
- Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
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Budapest, Hongarije, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
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Budapest, Hongarije, 1082
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
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Budapest, Hongarije, 1096
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
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Debrecen, Hongarije, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)
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Borsod-Abauj Zemplen county
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Miskolc, Borsod-Abauj Zemplen county, Hongarije, 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, Hongarije
- Bajai Szent Rókus Kórház ( Site 0386)
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Kecskemét, Bács-Kiskun county, Hongarije, 6000
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hongarije, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
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Shatin, Hongkong
- Prince of Wales Hospital ( Site 0926)
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Tuenmen, Hongkong, 999077
- Tuen Mun Hospital ( Site 0927)
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Parma, Italië, 43126
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
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Lazio
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Rome, Lazio, Italië, 00165
- Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
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Rome, Lazio, Italië, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
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Lombardy
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Milan, Lombardy, Italië, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
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Milan, Lombardy, Italië, 20154
- ASST Fatebenefratelli Sacco ( Site 0434)
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Veneto
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Padova, Veneto, Italië, 35128
- Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
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Shizuoka, Japan, 422-8527
- Shizuoka Saiseikai General Hospital ( Site 0456)
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Tokyo, Japan, 157-8535
- National Center for Child Health and Development ( Site 0455)
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Fukuoka
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Fukuoka, Fukuoka, Japan, 813-0017
- Fukuoka Children's Hospital ( Site 0452)
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Iizuka, Fukuoka, Japan, 820-8505
- Iizuka Hospital ( Site 0457)
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Kitakyushu-shi, Fukuoka, Japan, 806-8501
- Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
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Gunma
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Maebashi, Gunma, Japan, 371-0811
- Maebashi Red Cross Hospital ( Site 0451)
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Ibaraki
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Mito, Ibaraki, Japan, 311-4145
- Ibaraki Children's Hospital ( Site 0458)
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Tokyo
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Itabashiku, Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital ( Site 0453)
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Kuala Lumpur, Maleisië, 50300
- Hospital Tunku Azizah-Paediatric ( Site 0481)
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Kelantan
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Kota Bharu, Kelantan, Maleisië, 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, Maleisië, 59100
- University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
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Pulau Pinang
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George Town, Pulau Pinang, Maleisië, 10450
- Hospital Pulau Pinang ( Site 0482)
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Sabah
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Kota Kinabalu, Sabah, Maleisië, 88996
- Sabah Women and Children Hospital ( Site 0478)
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Sarawak
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Sibu, Sarawak, Maleisië, 96000
- Hospital Sibu ( Site 0476)
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Durango, Mexico, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
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Oaxaca City, Mexico, 68000
- Oaxaca Site Management Organization ( Site 0504)
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San Luis Potosí City, Mexico, 78209
- ONCOLOGICO POTOSINO, S.C. ( Site 0505)
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Guanajuato
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León, Guanajuato, Mexico, 37000
- Morales Vargas Centro de Investigacion ( Site 0509)
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Jalisco
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Guadalajara, Jalisco, Mexico, 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, Mexico, 04530
- Instituto Nacional de Pediatria ( Site 0506)
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Auckland, Nieuw-Zeeland, 2025
- Middlemore Clinical Trials ( Site 0526)
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Wellington Region
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Newtown, Wellington Region, Nieuw-Zeeland, 6021
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
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Oslo, Noorwegen, 0450
- Oslo Universitetssykehus Ullevål ( Site 0551)
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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, Puerto Rico, 00935
- UPR Medical Sciences Campus-Pediatrics ( Site 0626)
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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, Spanje, 28046
- Hospital Universitario La Paz ( Site 0726)
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Málaga, Spanje, 29015
- Grupo Pediatrico Uncibay ( Site 0734)
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Barcelona
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Badalona, Barcelona, Spanje, 08916
- Hospital Germans Trias i Pujol ( Site 0738)
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Esplugues de Llobregat, Barcelona, Spanje, 08950
- Hospital Sant Joan de Déu ( Site 0730)
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Sant Cugat del Vallès, Barcelona, Spanje, 08195
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
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La Coruna
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Santiago de Compostela, La Coruna, Spanje, 15706
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
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Madrid
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Boadilla del Monte, Madrid, Spanje, 28660
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
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Pozuelo de Alarcón, Madrid, Spanje, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanje, 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, Spanje, 33011
- Hospital Universitario Central de Asturias ( Site 0740)
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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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Bangkok
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Bangkok, Bangkok, Thailand, 10330
- Chulalongkorn University-Pediatrics ( Site 0777)
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Bangkok, Bangkok, Thailand, 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, Thailand, 90110
- Songklanagarind hospital-Department of Pediatrics ( Site 0776)
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Tsjechië, 708 52
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
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Praha 4
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Prague, Praha 4, Tsjechië, 14700
- Institute for the Care of Mother and Child ( Site 0251)
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Ankara, Turkije (Türkiye), 06100
- Ankara University Hospital Cebeci ( Site 0801)
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Ankara, Turkije (Türkiye), 06560
- Gazi Universitesi ( Site 0806)
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Ankara, Turkije (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)
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Kayseri, Turkije (Türkiye), 38039
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)
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Adana
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Sarçam, Adana, Turkije (Türkiye), 01030
- cukurova universty ( Site 0805)
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Liverpool, Verenigd Koninkrijk, L12 2AP
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
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England
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London, England, Verenigd Koninkrijk, E11 1NR
- Whipps Cross University Hospital ( Site 0846)
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London, England, Verenigd Koninkrijk, SW17 0RE
- St. George's Hospital ( Site 0845)
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Glasgow City
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Glasgow, Glasgow City, Verenigd Koninkrijk, G51 4TF
- Queen Elizabeth University Hospital ( Site 0842)
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Great Britain
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London, Great Britain, Verenigd Koninkrijk, SE1 7EH
- Evelina London Children's Hospital ( Site 0829)
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Hampshire
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Southampton, Hampshire, Verenigd Koninkrijk, SO16 0YD
- Southampton General Hospital ( Site 0826)
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London, City of
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London, London, City of, Verenigd Koninkrijk, E1 1BB
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
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Oxfordshire
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Oxford, Oxfordshire, Verenigd Koninkrijk, OX3 9DU
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
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California
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Long Beach, California, Verenigde Staten, 90806
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
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Orange, California, Verenigde Staten, 92868
- Children's Hospital of Orange County ( Site 0047)
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Children's Hospital Colorado ( Site 0011)
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20010
- Children's National Medical Center ( Site 0020)
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Florida
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Orlando, Florida, Verenigde Staten, 32827
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)
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Orlando, Florida, Verenigde Staten, 32806
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
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Tampa, Florida, Verenigde Staten, 33606
- University of South Florida-Department of Pediatrics ( Site 0045)
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30310
- Morehouse School Of Medicine ( Site 0049)
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Idaho
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Idaho Falls, Idaho, Verenigde Staten, 83404
- Clinical Research Prime ( Site 0046)
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky HealthCare - Turfland ( Site 0044)
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70809
- Our Lady of the Lake Children's Hospital ( Site 0031)
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane University School of Medicine ( Site 0010)
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 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, Verenigde Staten, 08901
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)
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New York
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Mineola, New York, Verenigde Staten, 11501
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester Medical Center ( Site 0017)
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514
- The University of North Carolina at Chapel Hill ( Site 0035)
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Durham, North Carolina, Verenigde Staten, 27710
- Duke University ( Site 0021)
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Ohio
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Dayton, Ohio, Verenigde Staten, 45449
- Dayton Children's Hospital ( Site 0053)
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29607
- Tribe Clinical Research, LLC ( Site 0002)
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Texas
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Corpus Christi, Texas, Verenigde Staten, 78411
- Driscoll Children's Hospital ( Site 0025)
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Edinburg, Texas, Verenigde Staten, 78539
- DHR Health Institute for Research and Development ( Site 0029)
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San Antonio, Texas, Verenigde Staten, 78207
- Christus Children's-Clinical Research Center ( Site 0038)
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San Antonio, Texas, Verenigde Staten, 78229
- University Hospital-Pediatrics ( Site 0019)
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San Antonio, Texas, Verenigde Staten, 78249
- Road Runner Research, Ltd ( Site 0052)
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84113
- Intermountain - Primary Children's Hospital ( Site 0026)
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Washington
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Spokane, Washington, Verenigde Staten, 99202
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
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Spokane, Washington, Verenigde Staten, 99204
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
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Tacoma, Washington, Verenigde Staten, 98405
- MultiCare Health System-Baker Center ( Site 0036)
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Gauteng
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Boksburg, Gauteng, Zuid-Afrika, 1459
- Reimed ( Site 0706)
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Soweto, Gauteng, Zuid-Afrika, 2013
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Zuid-Afrika, 4001
- King Edward VIII Hospital ( Site 0704)
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Western Cape
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Cape Town, Western Cape, Zuid-Afrika, 7500
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
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Cape Town, Western Cape, Zuid-Afrika, 7500
- Panorama Medical Centre ( Site 0702)
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Cape Town, Western Cape, Zuid-Afrika, 7700
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
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Cape Town, Western Cape, Zuid-Afrika, 7824
- 2 Military Hospital ( Site 0708)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 1 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Deelnemers met een verhoogd risico op ernstige RSV-infectie adviseerden om palivizumab te ontvangen in overeenstemming met nationale of lokale richtlijnen of aanbevelingen van de professionele samenleving.
- Is beschikbaar om de nazorgperiode te volbrengen.
Uitsluitingscriteria:
- Vereist mechanische ventilatie op het moment van inschrijving.
- Heeft een levensverwachting
- Heeft een bekende lever- of nierdisfunctie, of chronische epileptische stoornis.
- Ligt in het ziekenhuis op het moment van randomisatie, tenzij ontslag binnen 7 dagen na randomisatie wordt verwacht.
- Heeft ernstige immunodeficiëntie of is ernstig immuungecompromitteerd.
- Heeft een bekende overgevoeligheid voor een van de bestanddelen van clesrovimab of palivizumab.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Clesrovimab
Deelnemers krijgen intramusculaire (IM) injecties van clesrovimab en placebo
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IM-injectie
Andere namen:
IM-injectie
|
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Actieve vergelijker: Palivizumab
Deelnemers krijgen IM-injecties.
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IM-injectie
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
30 november 2021
Primaire voltooiing (Werkelijk)
28 april 2025
Studie voltooiing (Werkelijk)
1 augustus 2025
Studieregistratiedata
Eerst ingediend
22 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2021
Eerst geplaatst (Werkelijk)
24 juni 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
17 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Infecties
- RNA-virusinfecties
- Virusziekten
- Pneumovirusinfecties
- Paramyxoviridae-infecties
- Mononegavirale infecties
- Infecties met respiratoir syncytieel virus
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Palivizumab
- MK-1654
Andere studie-ID-nummers
- 1654-007
- MK-1654-007 (Andere identificatie: MSD)
- jRCT2031210664 (Register-ID: jRCT)
- 2020-005996-11 (EudraCT-nummer)
- U1111-1278-0093 (Register-ID: UTN)
- 2022-500752-39-00 (Register-ID: EU CT)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .