RSV Infection Clinical Trial
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
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).
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | January 6, 2026 |
| Est. primary completion date | June 28, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 1 Year |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Mater Misericordiae Limited-Neonatalogy ( Site 0102) | Brisbane | Queensland |
| Australia | Telethon Kids Institute-Vaccine Trials Group ( Site 0101) | Nedlands | Western Australia |
| Canada | Alberta Children's Hospital-Department of Pediatrics ( Site 0180) | Calgary | Alberta |
| Canada | Canadian Center for Vaccinology ( Site 0179) | Halifax | Nova Scotia |
| Canada | CHU Sainte-Justine ( Site 0178) | Montréal | Quebec |
| Chile | Clínica Alemana de Santiago-Neonatology department ( Site 0207) | Santiago | Region M. De Santiago |
| Chile | Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201) | Santiago | Region M. De Santiago |
| Chile | Hospital Roberto del Río-Infectología Pediátrica ( Site 0205) | Santiago | Region M. De Santiago |
| Colombia | Ciensalud Ips S A S ( Site 0235) | Barranquilla | Atlantico |
| Colombia | Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230) | Bogota | Distrito Capital De Bogota |
| Colombia | Clínica Imbanaco S.A.S ( Site 0229) | Cali | Valle Del Cauca |
| Colombia | Clínica Universitaria Bolivariana ( Site 0227) | Medellin | Antioquia |
| Colombia | Fundación Hospitalaria San Vicente de Paúl ( Site 0233) | Medellin | Antioquia |
| Czechia | Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252) | Ostrava | Moravskoslezsky Kraj |
| Czechia | Institute for the Care of Mother and Child ( Site 0251) | Prague | Praha 4 |
| Finland | MeVac - Meilahti Vaccine Research Center ( Site 0306) | Helsinki | Uusimaa |
| Finland | FVR, Kokkolan rokotetutkimusklinikka ( Site 0304) | Kokkola | Mellersta Osterbotten |
| Finland | FVR, Oulun rokotetutkimusklinikka ( Site 0303) | Oulu | Pohjois-Pohjanmaa |
| Finland | FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305) | Seinajoki | Sodra Osterbotten |
| Finland | FVR, Tampereen rokotetutkimusklinikka ( Site 0301) | Tampere | Pirkanmaa |
| Finland | FVR, Turun rokotetutkimusklinikka ( Site 0302) | Turku | Varsinais-Suomi |
| France | Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332) | Bordeaux | Aquitaine |
| France | Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq | Caen | Calvados |
| France | Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331) | Le Chesnay | Yvelines |
| Germany | Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin | Dresden | Sachsen |
| Germany | Universitaetsklinikum Freiburg ( Site 0365) | Freiburg | Baden-Wurttemberg |
| Germany | Medizinische Hochschule Hannover ( Site 0364) | Hannover | Niedersachsen |
| Germany | Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366) | Heidelberg | Baden-Wurttemberg |
| Germany | Universitätsklinikum Leipzig-Neonatology ( Site 0354) | Leipzig | Sachsen |
| Germany | Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361) | Lübeck | Schleswig-Holstein |
| Germany | Dr. von Haunersches Kinderspital ( Site 0358) | Munich | Bayern |
| Germany | München Klinik Harlaching ( Site 0351) | Munich | Bayern |
| Germany | Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359) | Oberhausen | Nordrhein-Westfalen |
| Greece | Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi | Athens | Attiki |
| Greece | Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854) | Athens | Attiki |
| Greece | ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855) | Chaidari | Attiki |
| Greece | Hippokration University Hopsital-3rd Pediatric Department ( Site 0851) | Thessaloniki | Kentriki Makedonia |
| Hong Kong | Prince of Wales Hospital ( Site 0926) | Shatin | |
| Hong Kong | Tuen Mun Hospital ( Site 0927) | Tuen Mun | |
| Hungary | Bajai Szent Rókus Kórház ( Site 0386) | Baja | Bacs-Kiskun |
| Hungary | Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383) | Budapest | |
| Hungary | Péterfy Kórház-Rendelointézet és Manninger Jeno Országos Traumatológiai Intézet-PIC ( Site 0384) | Budapest | |
| Hungary | Semmelweis University-Szülészeti és Nogyógyászati Klinika PIC ( Site 0381) | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont ( Site 0378) | Debrecen | |
| Hungary | Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380) | Kecskemét | Bacs-Kiskun |
| Hungary | Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si | Miskolc | Borsod-Abauj-Zemplen |
| Hungary | Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376) | Nyiregyhaza | Szabolcs-Szatmar-Bereg |
| Italy | ASST Fatebenefratelli Sacco ( Site 0434) | Milan | Lombardia |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432) | Milano | Lombardia |
| Italy | Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428) | Padova | Veneto |
| Italy | Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433) | Parma | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426) | Roma | Lazio |
| Italy | Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427) | Rome | Lazio |
| Japan | Fukuoka Children's Hospital ( Site 0452) | Fukuoka-shi | Fukuoka |
| Japan | Aso Iizuka Hospital ( Site 0457) | Iizuka | Fukuoka |
| Japan | Nihon University Itabashi Hospital ( Site 0453) | Itabashiku | Tokyo |
| Japan | Japan Community Healthcare Organization Kyushu Hospital ( Site 0454) | Kitakyushu-shi | Fukuoka |
| Japan | Maebashi Red Cross Hospital ( Site 0451) | Maebashi | Gunma |
| Japan | Ibaraki Children's Hospital ( Site 0458) | Mito | Ibaraki |
| Japan | Shizuoka Saiseikai General Hospital ( Site 0456) | Shizuoka | |
| Japan | National Center for Child Health and Development ( Site 0455) | Tokyo | |
| Malaysia | Hospital Pulau Pinang ( Site 0482) | George Town | Pulau Pinang |
| Malaysia | Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477) | Kota Bharu | Kelantan |
| Malaysia | Sabah Women and Children Hospital ( Site 0478) | Kota Kinabalu | Sabah |
| Malaysia | Hospital Tunku Azizah-Paediatric ( Site 0481) | Kuala Lumpur | |
| Malaysia | University Malaya Medical Centre-Department of Paediatrics ( Site 0480) | Lembah Pantai | Kuala Lumpur |
| Malaysia | Hospital Sibu ( Site 0476) | Sibu | Sarawak |
| Mexico | Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508) | Durango | |
| Mexico | Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502) | Guadalajara | Jalisco |
| Mexico | Morales Vargas Centro de Investigacion ( Site 0509) | León | Guanajuato |
| Mexico | Instituto Nacional de Pediatria ( Site 0506) | Mexico City | Distrito Federal |
| Mexico | Oaxaca Site Management Organization ( Site 0504) | Oaxaca | |
| Mexico | ONCOLOGICO POTOSINO, S.C. ( Site 0505) | San Luis Potosi | |
| New Zealand | Middlemore Clinical Trials ( Site 0526) | Auckland | |
| New Zealand | Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527) | Newtown | Wellington |
| Norway | Oslo Universitetssykehus Ullevål ( Site 0551) | Oslo | |
| Peru | Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577) | Jesús María | Lima |
| Peru | HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576) | Lima | |
| Puerto Rico | UPR Medical Sciences Campus-Pediatrics ( Site 0626) | San Juan | |
| Singapore | KK Women's and Children's Hospital-Department of Neonatology ( Site 0877) | Singapore | South West |
| South Africa | Reimed ( Site 0706) | Boksburg | Gauteng |
| South Africa | 2 Military Hospital ( Site 0708) | Cape Town | Western Cape |
| South Africa | Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703) | Cape Town | Western Cape |
| South Africa | MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710) | Cape Town | Western Cape |
| South Africa | Panorama Medical Centre ( Site 0702) | Cape Town | Western Cape |
| South Africa | King Edward VIII Hospital ( Site 0704) | Durban | Kwazulu-Natal |
| South Africa | Chris Hani Baragwanath Academic Hospital ( Site 0701) | Soweto | Gauteng |
| Spain | Hospital Germans Trias i Pujol ( Site 0738) | Badalona | Barcelona |
| Spain | Hospital Universitario HM Monteprincipe-pediatric ( Site 0743) | Boadilla del Monte | Madrid |
| Spain | Hospital Sant Joan de Déu ( Site 0730) | Esplugues de Llobregat | Barcelona |
| Spain | Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07 | Madrid | |
| Spain | Hospital Universitario La Paz ( Site 0726) | Madrid | |
| Spain | Grupo Pediatrico Uncibay ( Site 0734) | Malaga | |
| Spain | Hospital Universitario Central de Asturias ( Site 0740) | Oviedo | Asturias |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739) | Pozuelo de Alarcon | Madrid |
| Spain | Hospital Universitary General de Catalunya-Pediatrics ( Site 0737) | Sant Cugat del Vallès | Barcelona |
| Spain | CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731) | Santiago de Compostela | La Coruna |
| Taiwan | Taichung Veterans General Hospital ( Site 0754) | Taichung | |
| Taiwan | Mackay Memorial Hospital-Pediatrics ( Site 0753) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 0751) | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 0752) | Taoyuan | |
| Thailand | Chulalongkorn University-Pediatrics ( Site 0777) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Songklanagarind hospital-Department of Pediatrics ( Site 0776) | Hat Yai | Songkhla |
| Turkey | Ankara Bilkent Sehir Hastanesi. ( Site 0807) | Ankara | |
| Turkey | Ankara University Hospital Cebeci ( Site 0801) | Ankara | |
| Turkey | Gazi Universitesi ( Site 0806) | Ankara | |
| Turkey | Erciyes University Medical Faculty-pediatric infection ( Site 0804) | Kayseri | |
| Turkey | cukurova universty ( Site 0805) | Sarçam | Adana |
| United Kingdom | Queen Elizabeth University Hospital ( Site 0842) | Glasgow | Glasgow City |
| United Kingdom | Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843) | Liverpool | |
| United Kingdom | Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844) | London | London, City Of |
| United Kingdom | Evelina London Children's Hospital ( Site 0829) | London | Great Britain |
| United Kingdom | St. George's Hospital ( Site 0845) | London | England |
| United Kingdom | Whipps Cross University Hospital ( Site 0846) | London | England |
| United Kingdom | The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827) | Oxford | Oxfordshire |
| United Kingdom | Southampton General Hospital ( Site 0826) | Southampton | Hampshire |
| United States | Morehouse School Of Medicine ( Site 0049) | Atlanta | Georgia |
| United States | Children's Hospital Colorado ( Site 0011) | Aurora | Colorado |
| United States | Our Lady of the Lake Children's Hospital ( Site 0031) | Baton Rouge | Louisiana |
| United States | The University of North Carolina at Chapel Hill ( Site 0035) | Chapel Hill | North Carolina |
| United States | Driscoll Children's Hospital ( Site 0025) | Corpus Christi | Texas |
| United States | Dayton Children's Hospital ( Site 0053) | Dayton | Ohio |
| United States | Duke University ( Site 0021) | Durham | North Carolina |
| United States | DHR Health Institute for Research and Development ( Site 0029) | Edinburg | Texas |
| United States | Tribe Clinical Research, LLC ( Site 0002) | Greenville | South Carolina |
| United States | Clinical Research Prime ( Site 0046) | Idaho Falls | Idaho |
| United States | University of Kentucky HealthCare - Turfland ( Site 0044) | Lexington | Kentucky |
| United States | Miller Children's & Women's Hospital Long Beach ( Site 0001) | Long Beach | California |
| United States | NYU Langone Hospital - Long Island-Pediatrics ( Site 0028) | Mineola | New York |
| United States | M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit | Minneapolis | Minnesota |
| United States | Rutgers University-Pediatric Clinical Research Center ( Site 0007) | New Brunswick | New Jersey |
| United States | Tulane University School of Medicine ( Site 0010) | New Orleans | Louisiana |
| United States | Children's Hospital of Orange County ( Site 0047) | Orange | California |
| United States | Nemours Children's Health, Lake Nona Medical City ( Site 0032) | Orlando | Florida |
| United States | Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M | Orlando | Florida |
| United States | University of Rochester Medical Center ( Site 0017) | Rochester | New York |
| United States | Intermountain - Primary Children's Hospital ( Site 0026) | Salt Lake City | Utah |
| United States | Christus Children's-Clinical Research Center ( Site 0038) | San Antonio | Texas |
| United States | Road Runner Research, Ltd ( Site 0052) | San Antonio | Texas |
| United States | University Hospital-Pediatrics ( Site 0019) | San Antonio | Texas |
| United States | Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004) | Spokane | Washington |
| United States | Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030) | Spokane | Washington |
| United States | MultiCare Health System-Baker Center ( Site 0036) | Tacoma | Washington |
| United States | University of South Florida-Department of Pediatrics ( Site 0045) | Tampa | Florida |
| United States | Children's National Medical Center ( Site 0020) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Australia, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Peru, Puerto Rico, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1 | Percentage of participants with solicited injection-site AEs in RSV Season 1 | Up to 5 days | |
| Primary | Participants with solicited daily body temperature with fever in RSV Season 1 | Percentage of participants with solicited daily body temperature with fever in RSV Season 1 | Up to 5 days | |
| Primary | Participants with solicited systemic AEs in RSV Season 1 | Percentage of participants with solicited systemic AEs in RSV Season 1 | Up to 5 days | |
| Primary | Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1 | Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 | Up to 42 days | |
| Primary | Participants with rash AESI in RSV Season 1 | Percentage of participants with rash AESI in RSV Season 1 | Up to 42 days | |
| Primary | Participants with non-serious AEs in RSV Season 1 | Percentage of participants with non-serious AEs in RSV Season 1 | Up to 42 days | |
| Primary | Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 | Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 | Up to 365 days | |
| Secondary | Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 | Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 | Up to 150 days | |
| Secondary | Participants with RSV-associated hospitalization in RSV Season 1 | Percentage of participants with RSV-associated hospitalization in RSV Season 1 | Up to 150 days | |
| Secondary | Participants with solicited injection-site AEs in RSV Season 2 | Percentage of participants with solicited injection-site AEs in RSV Season 2 | From approximately 393 days up to 400 days | |
| Secondary | Participants with solicited daily body temperature with fever in RSV Season 2 | Percentage of participants with solicited daily body temperature with fever in RSV Season 2 | From approximately 393 days up to 400 days | |
| Secondary | Participants with solicited systemic AEs in RSV Season 2 | Percentage of participants with solicited systemic AEs in RSV Season 2 | From approximately 393 days up to 400 days | |
| Secondary | Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 | Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 | From approximately 393 days up to 440 days | |
| Secondary | Participants with rash AESI in RSV Season 2 | Percentage of participants with rash AESI in RSV Season 2 | From approximately 393 days up to 440 days | |
| Secondary | Participants with non-serious AEs in RSV Season 2 | Percentage of participants with non-serious AEs in RSV Season 2 | From approximately 393 days up to 440 days | |
| Secondary | Participants with SAEs in RSV Season 2 | Percentage of participants with SAEs in RSV Season 2 | From approximately 393 days up to 575 days | |
| Secondary | Concentration of clesrovimab in RSV Season 1 | Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1 | Up to 240 days | |
| Secondary | Concentration of clesrovimab in RSV Season 2 | Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2 | From approximately 393 days up to 550 days |
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