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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04938830
Other study ID # 1654-007
Secondary ID MK-1654-007jRCT2
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 30, 2021
Est. completion date October 27, 2025

Study information

Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date October 27, 2025
Est. primary completion date April 29, 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Clesrovimab
IM injection
Palivizumab
IM injection
Placebo
IM injection

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

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, 

Outcome

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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