Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Phase 3

Active, not recruiting

• Conditions: RSV Infection
• Interventions: Biological: Palivizumab; Biological: Clesrovimab; Biological: Placebo

• Registration Number: NCT04938830
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-24
• Study Start: 2021-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-04-29
• Study Completion: 2025-10-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clesrovimab	Placebo	Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Palivizumab	Palivizumab	Participants will receive IM injections.
Clesrovimab	Clesrovimab	Participants will receive intramuscular (IM) injections of clesrovimab and placebo

Primary Outcome Measures

Name	Time	Method
Participants with solicited daily body temperature with fever in RSV Season 1	Up to 5 days	Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Participants with non-serious AEs in RSV Season 1	Up to 42 days	Percentage of participants with non-serious AEs in RSV Season 1
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1	Up to 365 days	Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1	Up to 42 days	Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Participants with rash AESI in RSV Season 1	Up to 42 days	Percentage of participants with rash AESI in RSV Season 1
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1	Up to 5 days	Percentage of participants with solicited injection-site AEs in RSV Season 1
Participants with solicited systemic AEs in RSV Season 1	Up to 5 days	Percentage of participants with solicited systemic AEs in RSV Season 1

Secondary Outcome Measures

Name	Time	Method
Participants with RSV-associated hospitalization in RSV Season 1	Up to 150 days	Percentage of participants with RSV-associated hospitalization in RSV Season 1
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2	From approximately 393 days up to 440 days	Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1	Up to 150 days	Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Participants with solicited systemic AEs in RSV Season 2	From approximately 393 days up to 400 days	Percentage of participants with solicited systemic AEs in RSV Season 2
Participants with rash AESI in RSV Season 2	From approximately 393 days up to 440 days	Percentage of participants with rash AESI in RSV Season 2
Participants with non-serious AEs in RSV Season 2	From approximately 393 days up to 440 days	Percentage of participants with non-serious AEs in RSV Season 2
Concentration of clesrovimab in RSV Season 1	Up to 240 days	Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1
Participants with SAEs in RSV Season 2	From approximately 393 days up to 575 days	Percentage of participants with SAEs in RSV Season 2
Concentration of clesrovimab in RSV Season 2	From approximately 393 days up to 550 days	Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
Participants with solicited injection-site AEs in RSV Season 2	From approximately 393 days up to 400 days	Percentage of participants with solicited injection-site AEs in RSV Season 2
Participants with solicited daily body temperature with fever in RSV Season 2	From approximately 393 days up to 400 days	Percentage of participants with solicited daily body temperature with fever in RSV Season 2

Trial Locations

Locations (146)

DHR Health Institute for Research and Development ( Site 0029); 🇺🇸 Edinburg, Texas, United States

NYU Langone Hospital - Long Island-Pediatrics ( Site 0028); 🇺🇸 Mineola, New York, United States

Miller Children's & Women's Hospital Long Beach ( Site 0001); 🇺🇸 Long Beach, California, United States

Children's Hospital of Orange County ( Site 0047); 🇺🇸 Orange, California, United States

Dayton Children's Hospital ( Site 0053); 🇺🇸 Dayton, Ohio, United States

Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252); 🇨🇿 Ostrava, Moravskoslezsky Kraj, Czechia

Mater Misericordiae Limited-Neonatalogy ( Site 0102); 🇦🇺 Brisbane, Queensland, Australia

Institute for the Care of Mother and Child ( Site 0251); 🇨🇿 Prague, Praha 4, Czechia

Dr. von Haunersches Kinderspital ( Site 0358); 🇩🇪 Munich, Bayern, Germany

Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366); 🇩🇪 Heidelberg, Baden-Wurttemberg, Germany

Tribe Clinical Research, LLC ( Site 0002); 🇺🇸 Greenville, South Carolina, United States

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin; 🇩🇪 Dresden, Sachsen, Germany

FVR, Oulun rokotetutkimusklinikka ( Site 0303); 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332); 🇫🇷 Bordeaux, Aquitaine, France

Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527); 🇳🇿 Newtown, Wellington, New Zealand

München Klinik Harlaching ( Site 0351); 🇩🇪 Munich, Bayern, Germany

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305); 🇫🇮 Seinajoki, Sodra Osterbotten, Finland

Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq; 🇫🇷 Caen, Calvados, France

Chris Hani Baragwanath Academic Hospital ( Site 0701); 🇿🇦 Soweto, Gauteng, South Africa

Universitaetsklinikum Freiburg ( Site 0365); 🇩🇪 Freiburg, Baden-Wurttemberg, Germany

King Edward VIII Hospital ( Site 0704); 🇿🇦 Durban, Kwazulu-Natal, South Africa

Fukuoka Children's Hospital ( Site 0452); 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Aso Iizuka Hospital ( Site 0457); 🇯🇵 Iizuka, Fukuoka, Japan

National Center for Child Health and Development ( Site 0455); 🇯🇵 Tokyo, Japan

Instituto Nacional de Pediatria ( Site 0506); 🇲🇽 Mexico City, Distrito Federal, Mexico

Gazi Universitesi ( Site 0806); 🇹🇷 Ankara, Turkey

Reimed ( Site 0706); 🇿🇦 Boksburg, Gauteng, South Africa

Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502); 🇲🇽 Guadalajara, Jalisco, Mexico

Middlemore Clinical Trials ( Site 0526); 🇳🇿 Auckland, New Zealand

Hospital Universitary General de Catalunya-Pediatrics ( Site 0737); 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain

Hospital Germans Trias i Pujol ( Site 0738); 🇪🇸 Badalona, Barcelona, Spain

Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384); 🇭🇺 Budapest, Hungary

Clinical Research Prime ( Site 0046); 🇺🇸 Idaho Falls, Idaho, United States

Our Lady of the Lake Children's Hospital ( Site 0031); 🇺🇸 Baton Rouge, Louisiana, United States

Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030); 🇺🇸 Spokane, Washington, United States

Fundación Hospitalaria San Vicente de Paúl ( Site 0233); 🇨🇴 Medellin, Antioquia, Colombia

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201); 🇨🇱 Santiago, Region M. De Santiago, Chile

Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331); 🇫🇷 Le Chesnay, Yvelines, France

Medizinische Hochschule Hannover ( Site 0364); 🇩🇪 Hannover, Niedersachsen, Germany

Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359); 🇩🇪 Oberhausen, Nordrhein-Westfalen, Germany

Universitätsklinikum Leipzig-Neonatology ( Site 0354); 🇩🇪 Leipzig, Sachsen, Germany

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi; 🇬🇷 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, Greece

Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381); 🇭🇺 Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0378); 🇭🇺 Debrecen, Hungary

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383); 🇭🇺 Budapest, Hungary

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

HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576); 🇵🇪 Lima, Peru

Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577); 🇵🇪 Jesús María, Lima, Peru

Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703); 🇿🇦 Cape Town, Western Cape, South Africa

Panorama Medical Centre ( Site 0702); 🇿🇦 Cape Town, Western Cape, South Africa

2 Military Hospital ( Site 0708); 🇿🇦 Cape Town, Western Cape, South Africa

Hospital Universitario Central de Asturias ( Site 0740); 🇪🇸 Oviedo, Asturias, Spain

Hospital Sant Joan de Déu ( Site 0730); 🇪🇸 Esplugues de Llobregat, Barcelona, Spain

CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731); 🇪🇸 Santiago de Compostela, La Coruna, Spain

Hospital Universitario HM Monteprincipe-pediatric ( Site 0743); 🇪🇸 Boadilla del Monte, Madrid, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739); 🇪🇸 Pozuelo de Alarcon, Madrid, 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

Taichung Veterans General Hospital ( Site 0754); 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital ( Site 0751); 🇨🇳 Taipei, Taiwan

Chulalongkorn University-Pediatrics ( Site 0777); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Mackay Memorial Hospital-Pediatrics ( Site 0753); 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0752); 🇨🇳 Taoyuan, Taiwan

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Ankara University Hospital Cebeci ( Site 0801); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi. ( Site 0807); 🇹🇷 Ankara, Turkey

Erciyes University Medical Faculty-pediatric infection ( Site 0804); 🇹🇷 Kayseri, Turkey

Whipps Cross University Hospital ( Site 0846); 🇬🇧 London, England, United Kingdom

Queen Elizabeth University Hospital ( Site 0842); 🇬🇧 Glasgow, Glasgow City, United Kingdom

Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844); 🇬🇧 London, London, City Of, United Kingdom

Southampton General Hospital ( Site 0826); 🇬🇧 Southampton, Hampshire, United Kingdom

Evelina London Children's Hospital ( Site 0829); 🇬🇧 London, Great Britain, United Kingdom

Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843); 🇬🇧 Liverpool, United Kingdom

Morehouse School Of Medicine ( Site 0049); 🇺🇸 Atlanta, Georgia, United States

M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit; 🇺🇸 Minneapolis, Minnesota, United States

Duke University ( Site 0021); 🇺🇸 Durham, North Carolina, 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

Morales Vargas Centro de Investigacion ( Site 0509); 🇲🇽 León, Guanajuato, Mexico

Telethon Kids Institute-Vaccine Trials Group ( Site 0101); 🇦🇺 Nedlands, Western Australia, Australia

Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361); 🇩🇪 Lübeck, Schleswig-Holstein, Germany

cukurova universty ( Site 0805); 🇹🇷 Sarçam, Adana, Turkey

Songklanagarind hospital-Department of Pediatrics ( Site 0776); 🇹🇭 Hat Yai, Songkhla, Thailand

ASST Fatebenefratelli Sacco ( Site 0434); 🇮🇹 Milan, Lombardia, Italy

Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433); 🇮🇹 Parma, Italy

Driscoll Children's Hospital ( Site 0025); 🇺🇸 Corpus Christi, Texas, United States

University Hospital-Pediatrics ( Site 0019); 🇺🇸 San Antonio, Texas, United States

MultiCare Health System-Baker Center ( Site 0036); 🇺🇸 Tacoma, Washington, United States

Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004); 🇺🇸 Spokane, Washington, United States

Hospital Roberto del Río-Infectología Pediátrica ( Site 0205); 🇨🇱 Santiago, Region M. De Santiago, Chile

Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854); 🇬🇷 Athens, Attiki, Greece

Bajai Szent Rókus Kórház ( Site 0386); 🇭🇺 Baja, Bacs-Kiskun, Hungary

Maebashi Red Cross Hospital ( Site 0451); 🇯🇵 Maebashi, Gunma, Japan

University Malaya Medical Centre-Department of Paediatrics ( Site 0480); 🇲🇾 Lembah Pantai, Kuala Lumpur, Malaysia

Oaxaca Site Management Organization ( Site 0504); 🇲🇽 Oaxaca, Mexico

Alberta Children's Hospital-Department of Pediatrics ( Site 0180); 🇨🇦 Calgary, Alberta, Canada

Sabah Women and Children Hospital ( Site 0478); 🇲🇾 Kota Kinabalu, Sabah, Malaysia

FVR, Turun rokotetutkimusklinikka ( Site 0302); 🇫🇮 Turku, Varsinais-Suomi, Finland

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426); 🇮🇹 Roma, Lazio, Italy

Hospital Pulau Pinang ( Site 0482); 🇲🇾 George Town, Pulau Pinang, Malaysia

Oslo Universitetssykehus Ullevål ( Site 0551); 🇳🇴 Oslo, Norway

MeVac - Meilahti Vaccine Research Center ( Site 0306); 🇫🇮 Helsinki, Uusimaa, Finland

Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477); 🇲🇾 Kota Bharu, Kelantan, Malaysia

Clínica Alemana de Santiago-Neonatology department ( Site 0207); 🇨🇱 Santiago, Region M. De Santiago, Chile

Ciensalud Ips S A S ( Site 0235); 🇨🇴 Barranquilla, Atlantico, Colombia

FVR, Kokkolan rokotetutkimusklinikka ( Site 0304); 🇫🇮 Kokkola, Mellersta Osterbotten, Finland

Japan Community Healthcare Organization Kyushu Hospital ( Site 0454); 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Rutgers University-Pediatric Clinical Research Center ( Site 0007); 🇺🇸 New Brunswick, New Jersey, United States

FVR, Tampereen rokotetutkimusklinikka ( Site 0301); 🇫🇮 Tampere, Pirkanmaa, Finland

CHU Sainte-Justine ( Site 0178); 🇨🇦 Montréal, Quebec, Canada

Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230); 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Ibaraki Children's Hospital ( Site 0458); 🇯🇵 Mito, Ibaraki, Japan

Hospital Tunku Azizah-Paediatric ( Site 0481); 🇲🇾 Kuala Lumpur, Malaysia

ONCOLOGICO POTOSINO, S.C. ( Site 0505); 🇲🇽 San Luis Potosi, Mexico

UPR Medical Sciences Campus-Pediatrics ( Site 0626); 🇵🇷 San Juan, Puerto Rico

Canadian Center for Vaccinology ( Site 0179); 🇨🇦 Halifax, Nova Scotia, Canada

The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827); 🇬🇧 Oxford, Oxfordshire, United Kingdom

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710); 🇿🇦 Cape Town, Western Cape, South Africa

St. George's Hospital ( Site 0845); 🇬🇧 London, England, United Kingdom

Children's National Medical Center ( Site 0020); 🇺🇸 Washington, District of Columbia, United States

Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427); 🇮🇹 Rome, Lazio, Italy

Clínica Universitaria Bolivariana ( Site 0227); 🇨🇴 Medellin, Antioquia, Colombia

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, Hungary

Nihon University Itabashi Hospital ( Site 0453); 🇯🇵 Itabashiku, Tokyo, Japan

Shizuoka Saiseikai General Hospital ( Site 0456); 🇯🇵 Shizuoka, Japan

Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508); 🇲🇽 Durango, Mexico

KK Women's and Children's Hospital-Department of Neonatology ( Site 0877); 🇸🇬 Singapore, South West, Singapore

Clínica Imbanaco S.A.S ( Site 0229); 🇨🇴 Cali, Valle Del Cauca, Colombia

Hospital Sibu ( Site 0476); 🇲🇾 Sibu, Sarawak, Malaysia

Children's Hospital Colorado ( Site 0011); 🇺🇸 Aurora, Colorado, United States

Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M; 🇺🇸 Orlando, Florida, United States

University of South Florida-Department of Pediatrics ( Site 0045); 🇺🇸 Tampa, Florida, United States

Nemours Children's Health, Lake Nona Medical City ( Site 0032); 🇺🇸 Orlando, Florida, United States

University of Kentucky HealthCare - Turfland ( Site 0044); 🇺🇸 Lexington, Kentucky, United States

Tulane University School of Medicine ( Site 0010); 🇺🇸 New Orleans, Louisiana, United States

University of Rochester Medical Center ( Site 0017); 🇺🇸 Rochester, New York, United States

The University of North Carolina at Chapel Hill ( Site 0035); 🇺🇸 Chapel Hill, North Carolina, United States

Intermountain - Primary Children's Hospital ( Site 0026); 🇺🇸 Salt Lake City, Utah, United States

Tuen Mun Hospital ( Site 0927); 🇭🇰 Tuen Mun, Hong Kong

Prince of Wales Hospital ( Site 0926); 🇭🇰 Shatin, Hong Kong