Clesrovimab (MK-1654) hos spædbørn og børn med øget risiko for alvorlig respiratorisk syncytialvirus (RSV) sygdom (MK-1654-007) (SMART)
17. april 2026 opdateret af: Merck Sharp & Dohme LLC
En fase 3, multicenter, randomiseret, delvist blindet, palivizumab-kontrolleret undersøgelse for at evaluere sikkerheden, effektiviteten og farmakokinetikken af MK-1654 hos spædbørn og børn med øget risiko for alvorlig RSV-sygdom
Denne undersøgelse har til formål at evaluere sikkerheden og tolerabiliteten af clesrovimab sammenlignet med palivizumab som vurderet af andelen af deltagere, der oplever bivirkninger (AE'er).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
1003
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@merck.com
Studiesteder
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Queensland
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Brisbane, Queensland, Australien, 4101
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)
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Western Australia
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Nedlands, Western Australia, Australien, 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, 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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Liverpool, Det Forenede Kongerige, L12 2AP
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
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England
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London, England, Det Forenede Kongerige, E11 1NR
- Whipps Cross University Hospital ( Site 0846)
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London, England, Det Forenede Kongerige, SW17 0RE
- St. George's Hospital ( Site 0845)
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Glasgow City
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Glasgow, Glasgow City, Det Forenede Kongerige, G51 4TF
- Queen Elizabeth University Hospital ( Site 0842)
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Great Britain
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London, Great Britain, Det Forenede Kongerige, SE1 7EH
- Evelina London Children's Hospital ( Site 0829)
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Hampshire
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Southampton, Hampshire, Det Forenede Kongerige, SO16 0YD
- Southampton General Hospital ( Site 0826)
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London, City of
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London, London, City of, Det Forenede Kongerige, E1 1BB
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
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Oxfordshire
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Oxford, Oxfordshire, Det Forenede Kongerige, OX3 9DU
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
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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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California
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Long Beach, California, Forenede Stater, 90806
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County ( Site 0047)
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado ( Site 0011)
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Children's National Medical Center ( Site 0020)
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Florida
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Orlando, Florida, Forenede Stater, 32827
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)
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Orlando, Florida, Forenede Stater, 32806
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
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Tampa, Florida, Forenede Stater, 33606
- University of South Florida-Department of Pediatrics ( Site 0045)
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Georgia
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Atlanta, Georgia, Forenede Stater, 30310
- Morehouse School Of Medicine ( Site 0049)
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Clinical Research Prime ( Site 0046)
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky HealthCare - Turfland ( Site 0044)
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Our Lady of the Lake Children's Hospital ( Site 0031)
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine ( Site 0010)
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 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, Forenede Stater, 08901
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)
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New York
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Mineola, New York, Forenede Stater, 11501
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center ( Site 0017)
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- The University of North Carolina at Chapel Hill ( Site 0035)
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Durham, North Carolina, Forenede Stater, 27710
- Duke University ( Site 0021)
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Ohio
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Dayton, Ohio, Forenede Stater, 45449
- Dayton Children's Hospital ( Site 0053)
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Tribe Clinical Research, LLC ( Site 0002)
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Texas
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital ( Site 0025)
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Edinburg, Texas, Forenede Stater, 78539
- DHR Health Institute for Research and Development ( Site 0029)
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San Antonio, Texas, Forenede Stater, 78207
- Christus Children's-Clinical Research Center ( Site 0038)
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San Antonio, Texas, Forenede Stater, 78229
- University Hospital-Pediatrics ( Site 0019)
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San Antonio, Texas, Forenede Stater, 78249
- Road Runner Research, Ltd ( Site 0052)
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Intermountain - Primary Children's Hospital ( Site 0026)
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Washington
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Spokane, Washington, Forenede Stater, 99202
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
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Spokane, Washington, Forenede Stater, 99204
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
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Tacoma, Washington, Forenede Stater, 98405
- MultiCare Health System-Baker Center ( Site 0036)
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Aquitaine
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Bordeaux, Aquitaine, Frankrig, 33076
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
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Calvados
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Caen, Calvados, Frankrig, 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, Frankrig, 78157
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
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Attica
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Athens, Attica, Grækenland, 115 27
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852)
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Athens, Attica, Grækenland, 115 27
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
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Chaïdári, Attica, Grækenland, 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, Grækenland, 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, Italien, 43126
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
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Lazio
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Rome, Lazio, Italien, 00165
- Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
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Rome, Lazio, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
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Lombardy
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Milan, Lombardy, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
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Milan, Lombardy, Italien, 20154
- ASST Fatebenefratelli Sacco ( Site 0434)
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Veneto
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Padova, Veneto, Italien, 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, 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, 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, New Zealand, 2025
- Middlemore Clinical Trials ( Site 0526)
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Wellington Region
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Newtown, Wellington Region, New Zealand, 6021
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
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Oslo, Norge, 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, Spanien, 28046
- Hospital Universitario La Paz ( Site 0726)
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Málaga, Spanien, 29015
- Grupo Pediatrico Uncibay ( Site 0734)
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Hospital Germans Trias i Pujol ( Site 0738)
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Esplugues de Llobregat, Barcelona, Spanien, 08950
- Hospital Sant Joan de Déu ( Site 0730)
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Sant Cugat del Vallès, Barcelona, Spanien, 08195
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
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La Coruna
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Santiago de Compostela, La Coruna, Spanien, 15706
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
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Madrid
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Boadilla del Monte, Madrid, Spanien, 28660
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 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, Spanien, 33011
- Hospital Universitario Central de Asturias ( Site 0740)
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Gauteng
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Boksburg, Gauteng, Sydafrika, 1459
- Reimed ( Site 0706)
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Soweto, Gauteng, Sydafrika, 2013
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sydafrika, 4001
- King Edward VIII Hospital ( Site 0704)
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Western Cape
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Cape Town, Western Cape, Sydafrika, 7500
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
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Cape Town, Western Cape, Sydafrika, 7500
- Panorama Medical Centre ( Site 0702)
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Cape Town, Western Cape, Sydafrika, 7700
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
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Cape Town, Western Cape, Sydafrika, 7824
- 2 Military Hospital ( Site 0708)
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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, Tjekkiet, 708 52
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
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Praha 4
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Prague, Praha 4, Tjekkiet, 14700
- Institute for the Care of Mother and Child ( Site 0251)
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Ankara, Tyrkiet (Türkiye), 06100
- Ankara University Hospital Cebeci ( Site 0801)
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Ankara, Tyrkiet (Türkiye), 06560
- Gazi Universitesi ( Site 0806)
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)
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Kayseri, Tyrkiet (Türkiye), 38039
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)
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Adana
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Sarçam, Adana, Tyrkiet (Türkiye), 01030
- cukurova universty ( Site 0805)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Universitaetsklinikum Freiburg ( Site 0365)
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Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
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Bavaria
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Munich, Bavaria, Tyskland, 80337
- Dr. von Haunersches Kinderspital ( Site 0358)
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Munich, Bavaria, Tyskland, 81545
- München Klinik Harlaching ( Site 0351)
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Lower Saxony
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Hanover, Lower Saxony, Tyskland, 30625
- Medizinische Hochschule Hannover ( Site 0364)
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North Rhine-Westphalia
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Oberhausen, North Rhine-Westphalia, Tyskland, 46145
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363)
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Leipzig, Saxony, Tyskland, 04103
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Tyskland, 23538
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
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Budapest, Ungarn, 1076
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
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Budapest, Ungarn, 1082
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
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Budapest, Ungarn, 1096
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)
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Borsod-Abauj Zemplen county
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Miskolc, Borsod-Abauj Zemplen county, Ungarn, 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, Ungarn
- Bajai Szent Rókus Kórház ( Site 0386)
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Kecskemét, Bács-Kiskun county, Ungarn, 6000
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 1 år (Barn)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Deltagere med øget risiko for alvorlig RSV-infektion anbefales at få palivizumab i overensstemmelse med nationale eller lokale retningslinjer eller anbefalinger fra det professionelle samfund.
- Er tilgængelig for at gennemføre opfølgningsperioden.
Ekskluderingskriterier:
- Kræver mekanisk ventilation ved tilmelding.
- Har en forventet levetid
- Har kendt lever- eller nyredysfunktion eller kronisk anfaldsforstyrrelse.
- Er indlagt på randomiseringstidspunktet, medmindre der forventes udskrivning inden for 7 dage efter randomisering.
- Har alvorlig immundefekt eller er alvorligt immunkompromitteret.
- Har kendt overfølsomhed over for en hvilken som helst komponent i clesrovimab eller palivizumab.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: Clesrovimab
Deltagerne vil modtage intramuskulære (IM) injektioner af clesrovimab og placebo
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IM injektion
Andre navne:
IM injektion
|
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Aktiv komparator: Palivizumab
Deltagerne vil modtage IM-injektioner.
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IM injektion
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Tidsramme: 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.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
30. november 2021
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
28. april 2025
Studieafslutning (Faktiske)
Studieafslutning
1. august 2025
Datoer for studieregistrering
Først indsendt
Først indsendt
22. juni 2021
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
22. juni 2021
Først opslået (Faktiske)
Først opslået
24. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
8. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. april 2026
Sidst verificeret
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Pneumovirus infektioner
- Paramyxoviridae infektioner
- Mononegavirales infektioner
- Respiratoriske syncytielle virusinfektioner
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Palivizumab
- MK-1654
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 1654-007
- MK-1654-007 (Anden identifikator: MSD)
- jRCT2031210664 (Registry Identifier: jRCT)
- 2020-005996-11 (EudraCT nummer)
- U1111-1278-0093 (Registry Identifier: UTN)
- 2022-500752-39-00 (Registry Identifier: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .