Clinical trial NCT04938830: Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Official title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: RSV Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 1003
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).


Eligibility criteria: Inclusion Criteria:

* Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
* Is available to complete the follow-up period.

Exclusion Criteria:

* Requires mechanical ventilation at time of enrollment.
* Has a life expectancy \<6 months.
* Has known hepatic or renal dysfunction, or chronic seizure disorder.
* Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
* Has severe immunodeficiency or is severely immunocompromised.
* Has known hypersensitivity to any component of clesrovimab or palivizumab.

Primary outcomes:
measure: Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
timeFrame: Up to 5 days
measure: Participants with solicited daily body temperature with fever in RSV Season 1
timeFrame: Up to 5 days
measure: Participants with solicited systemic AEs in RSV Season 1
timeFrame: Up to 5 days
measure: Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
timeFrame: Up to 42 days
measure: Participants with rash AESI in RSV Season 1
timeFrame: Up to 42 days
measure: Participants with non-serious AEs in RSV Season 1
timeFrame: Up to 42 days
measure: Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
timeFrame: Up to 365 days
Secondary outcomes:
measure: Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
timeFrame: Up to 150 days
measure: Participants with RSV-associated hospitalization in RSV Season 1
timeFrame: Up to 150 days
measure: Participants with solicited injection-site AEs in RSV Season 2
timeFrame: From approximately 393 days up to 400 days
measure: Participants with solicited daily body temperature with fever in RSV Season 2
timeFrame: From approximately 393 days up to 400 days
measure: Participants with solicited systemic AEs in RSV Season 2
timeFrame: From approximately 393 days up to 400 days
measure: Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
timeFrame: From approximately 393 days up to 440 days
measure: Participants with rash AESI in RSV Season 2
timeFrame: From approximately 393 days up to 440 days
measure: Participants with non-serious AEs in RSV Season 2
timeFrame: From approximately 393 days up to 440 days
measure: Participants with SAEs in RSV Season 2
timeFrame: From approximately 393 days up to 575 days
measure: Concentration of clesrovimab in RSV Season 1
timeFrame: Up to 240 days
measure: Concentration of clesrovimab in RSV Season 2
timeFrame: From approximately 393 days up to 550 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children's & Women's Hospital Long Beach ( Site 0001)
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County ( Site 0047)
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado ( Site 0011)
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center ( Site 0020)
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Health, Lake Nona Medical City ( Site 0032)
state: Florida
city: Tampa
country: United States
facility: University of South Florida-Department of Pediatrics ( Site 0045)
state: Florida
city: Atlanta
country: United States
facility: Morehouse School Of Medicine ( Site 0049)
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime ( Site 0046)
state: Idaho
city: Lexington
country: United States
facility: University of Kentucky HealthCare - Turfland ( Site 0044)
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Children's Hospital ( Site 0031)
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine ( Site 0010)
state: Louisiana
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers University-Pediatric Clinical Research Center ( Site 0007)
state: New Jersey
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center ( Site 0017)
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill ( Site 0035)
state: North Carolina
city: Durham
country: United States
facility: Duke University ( Site 0021)
state: North Carolina
city: Dayton
country: United States
facility: Dayton Children's Hospital ( Site 0053)
state: Ohio
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC ( Site 0002)
state: South Carolina
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital ( Site 0025)
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development ( Site 0029)
state: Texas
city: San Antonio
country: United States
facility: Christus Children's-Clinical Research Center ( Site 0038)
state: Texas
city: San Antonio
country: United States
facility: University Hospital-Pediatrics ( Site 0019)
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd ( Site 0052)
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain - Primary Children's Hospital ( Site 0026)
state: Utah
city: Spokane
country: United States
facility: Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System-Baker Center ( Site 0036)
state: Washington
city: Brisbane
country: Australia
facility: Mater Misericordiae Limited-Neonatalogy ( Site 0102)
state: Queensland
city: Nedlands
country: Australia
facility: Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
state: Western Australia
city: Calgary
country: Canada
facility: Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
state: Alberta
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology ( Site 0179)
state: Nova Scotia
city: Montréal
country: Canada
facility: CHU Sainte-Justine ( Site 0178)
state: Quebec
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago-Neonatology department ( Site 0207)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
state: Region M. De Santiago
city: Medellin
country: Colombia
facility: Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
state: Antioquia
city: Medellin
country: Colombia
facility: Clínica Universitaria Bolivariana ( Site 0227)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Ciensalud Ips S A S ( Site 0235)
state: Atlantico
city: Bogota
country: Colombia
facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S ( Site 0229)
state: Valle Del Cauca
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
state: Moravskoslezsky Kraj
city: Prague
country: Czechia
facility: Institute for the Care of Mother and Child ( Site 0251)
state: Praha 4
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
state: Mellersta Osterbotten
city: Tampere
country: Finland
facility: FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka ( Site 0303)
state: Pohjois-Pohjanmaa
city: Seinajoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
state: Sodra Osterbotten
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center ( Site 0306)
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka ( Site 0302)
state: Varsinais-Suomi
city: Bordeaux
country: France
facility: Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
state: Aquitaine
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
state: Calvados
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
state: Yvelines
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0365)
state: Baden-Wurttemberg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital ( Site 0358)
state: Bayern
city: Munich
country: Germany
facility: München Klinik Harlaching ( Site 0351)
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0364)
state: Niedersachsen
city: Oberhausen
country: Germany
facility: Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig-Neonatology ( Site 0354)
state: Sachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
state: Schleswig-Holstein
city: Athens
country: Greece
facility: Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi
state: Attiki
city: Athens
country: Greece
facility: Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
state: Attiki
city: Thessaloniki
country: Greece
facility: Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
state: Kentriki Makedonia
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 0926)
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital ( Site 0927)
city: Baja
country: Hungary
facility: Bajai Szent Rókus Kórház ( Site 0386)
state: Bacs-Kiskun
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
state: Bacs-Kiskun
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si
state: Borsod-Abauj-Zemplen
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
city: Budapest
country: Hungary
facility: Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 0378)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
state: Lazio
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
state: Lombardia
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco ( Site 0434)
state: Lombardia
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
state: Veneto
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
city: Fukuoka-shi
country: Japan
facility: Fukuoka Children's Hospital ( Site 0452)
state: Fukuoka
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital ( Site 0457)
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
state: Fukuoka
city: Maebashi
country: Japan
facility: Maebashi Red Cross Hospital ( Site 0451)
state: Gunma
city: Mito
country: Japan
facility: Ibaraki Children's Hospital ( Site 0458)
state: Ibaraki
city: Itabashiku
country: Japan
facility: Nihon University Itabashi Hospital ( Site 0453)
state: Tokyo
city: Shizuoka
country: Japan
facility: Shizuoka Saiseikai General Hospital ( Site 0456)
city: Tokyo
country: Japan
facility: National Center for Child Health and Development ( Site 0455)
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
state: Kelantan
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
state: Kuala Lumpur
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 0482)
state: Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Sabah Women and Children Hospital ( Site 0478)
state: Sabah
city: Sibu
country: Malaysia
facility: Hospital Sibu ( Site 0476)
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Tunku Azizah-Paediatric ( Site 0481)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria ( Site 0506)
state: Distrito Federal
city: León
country: Mexico
facility: Morales Vargas Centro de Investigacion ( Site 0509)
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
state: Jalisco
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization ( Site 0504)
city: San Luis Potosi
country: Mexico
facility: ONCOLOGICO POTOSINO, S.C. ( Site 0505)
city: Newtown
country: New Zealand
facility: Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
state: Wellington
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials ( Site 0526)
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål ( Site 0551)
city: Jesús María
country: Peru
facility: Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
state: Lima
city: Lima
country: Peru
facility: HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
city: San Juan
country: Puerto Rico
facility: UPR Medical Sciences Campus-Pediatrics ( Site 0626)
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
state: South West
city: Boksburg
country: South Africa
facility: Reimed ( Site 0706)
state: Gauteng
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital ( Site 0701)
state: Gauteng
city: Durban
country: South Africa
facility: King Edward VIII Hospital ( Site 0704)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
state: Western Cape
city: Cape Town
country: South Africa
facility: Panorama Medical Centre ( Site 0702)
state: Western Cape
city: Cape Town
country: South Africa
facility: MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
state: Western Cape
city: Cape Town
country: South Africa
facility: 2 Military Hospital ( Site 0708)
state: Western Cape
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias ( Site 0740)
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol ( Site 0738)
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu ( Site 0730)
state: Barcelona
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
state: La Coruna
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 0726)
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay ( Site 0734)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 0754)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0751)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital-Pediatrics ( Site 0753)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
city: Bangkok
country: Thailand
facility: Chulalongkorn University-Pediatrics ( Site 0777)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
state: Krung Thep Maha Nakhon
city: Hat Yai
country: Thailand
facility: Songklanagarind hospital-Department of Pediatrics ( Site 0776)
state: Songkhla
city: Sarçam
country: Turkey
facility: cukurova universty ( Site 0805)
state: Adana
city: Ankara
country: Turkey
facility: Ankara University Hospital Cebeci ( Site 0801)
city: Ankara
country: Turkey
facility: Gazi Universitesi ( Site 0806)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi. ( Site 0807)
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty-pediatric infection ( Site 0804)
city: London
country: United Kingdom
facility: Whipps Cross University Hospital ( Site 0846)
state: England
city: London
country: United Kingdom
facility: St. George's Hospital ( Site 0845)
state: England
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital ( Site 0842)
state: Glasgow City
city: London
country: United Kingdom
facility: Evelina London Children's Hospital ( Site 0829)
state: Great Britain
city: Southampton
country: United Kingdom
facility: Southampton General Hospital ( Site 0826)
state: Hampshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
state: London, City Of
city: Oxford
country: United Kingdom
facility: The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
state: Oxfordshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: