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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,003

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

April 28, 2025

Study Completion Date

August 1, 2025

Conditions
RSV Infection
Interventions
BIOLOGICAL

Clesrovimab

IM injection

BIOLOGICAL

Palivizumab

IM injection

BIOLOGICAL

Placebo

IM injection

Trial Locations (146)

407

Taichung Veterans General Hospital ( Site 0754), Taichung

1076

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

1082

Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381), Budapest

1096

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383), Budapest

1459

Reimed ( Site 0706), Boksburg

2013

Chris Hani Baragwanath Academic Hospital ( Site 0701), Soweto

2025

Middlemore Clinical Trials ( Site 0526), Auckland

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Site 0388), Miskolc

4001

King Edward VIII Hospital ( Site 0704), Durban

4032

Debreceni Egyetem Klinikai Kozpont ( Site 0378), Debrecen

4101

Mater Misericordiae Limited-Neonatalogy ( Site 0102), Brisbane

4400

Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz - Gyermekosztaly ( Site 0376), Nyíregyháza

6000

Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380), Kecskemét

6009

Telethon Kids Institute-Vaccine Trials Group ( Site 0101), Nedlands

6021

Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527), Newtown

7500

Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703), Cape Town

Panorama Medical Centre ( Site 0702), Cape Town

7700

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710), Cape Town

7824

2 Military Hospital ( Site 0708), Cape Town

10002

National Taiwan University Hospital ( Site 0751), Taipei

10330

Chulalongkorn University-Pediatrics ( Site 0777), Bangkok

10449

Mackay Memorial Hospital-Pediatrics ( Site 0753), Taipei

10450

Hospital Pulau Pinang ( Site 0482), George Town

10700

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778), Bangkok

11501

NYU Langone Hospital - Long Island-Pediatrics ( Site 0028), Mineola

14033

Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq ( Site 0330), Caen

14642

University of Rochester Medical Center ( Site 0017), Rochester

14700

Institute for the Care of Mother and Child ( Site 0251), Prague

15001

HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576), Lima

15072

Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577), Jesús María

15586

Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477), Kota Bharu

15706

CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731), Santiago de Compostela

20010

Children's National Medical Center ( Site 0020), Washington D.C.

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432), Milan

20154

ASST Fatebenefratelli Sacco ( Site 0434), Milan

20520

FVR, Turun rokotetutkimusklinikka ( Site 0302), Turku

23538

Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361), Lübeck

27514

The University of North Carolina at Chapel Hill ( Site 0035), Chapel Hill

27710

Duke University ( Site 0021), Durham

28041

Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 0728), Madrid

28046

Hospital Universitario La Paz ( Site 0726), Madrid

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739), Pozuelo de Alarcón

28660

Hospital Universitario HM Monteprincipe-pediatric ( Site 0743), Boadilla del Monte

29015

Grupo Pediatrico Uncibay ( Site 0734), Málaga

29607

Tribe Clinical Research, LLC ( Site 0002), Greenville

30310

Morehouse School Of Medicine ( Site 0049), Atlanta

30625

Medizinische Hochschule Hannover ( Site 0364), Hanover

32806

Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022), Orlando

32827

Nemours Children's Health, Lake Nona Medical City ( Site 0032), Orlando

33011

Hospital Universitario Central de Asturias ( Site 0740), Oviedo

33076

Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332), Bordeaux

33100

FVR, Tampereen rokotetutkimusklinikka ( Site 0301), Tampere

33305

Chang Gung Medical Foundation-Linkou Branch ( Site 0752), Taoyuan District

33606

University of South Florida-Department of Pediatrics ( Site 0045), Tampa

34000

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

35128

Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428), Padua

37000

Morales Vargas Centro de Investigacion ( Site 0509), León

38039

Erciyes University Medical Faculty-pediatric infection ( Site 0804), Kayseri

40536

University of Kentucky HealthCare - Turfland ( Site 0044), Lexington

43126

Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433), Parma

44650

Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502), Guadalajara

45449

Dayton Children's Hospital ( Site 0053), Dayton

46145

Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359), Oberhausen

50036

Clínica Universitaria Bolivariana ( Site 0227), Medellín

50300

Hospital Tunku Azizah-Paediatric ( Site 0481), Kuala Lumpur

54642

Hippokration University Hopsital-3rd Pediatric Department ( Site 0851), Thessaloniki

55454

M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Site 0037), Minneapolis

59100

University Malaya Medical Centre-Department of Paediatrics ( Site 0480), Lembah Pantai

60100

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305), Seinäjoki

67100

FVR, Kokkolan rokotetutkimusklinikka ( Site 0304), Kokkola

68000

Oaxaca Site Management Organization ( Site 0504), Oaxaca City

69120

Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366), Heidelberg

70112

Tulane University School of Medicine ( Site 0010), New Orleans

70809

Our Lady of the Lake Children's Hospital ( Site 0031), Baton Rouge

78157

Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331), Le Chesnay

78207

Christus Children's-Clinical Research Center ( Site 0038), San Antonio

78209

ONCOLOGICO POTOSINO, S.C. ( Site 0505), San Luis Potosí City

78229

University Hospital-Pediatrics ( Site 0019), San Antonio

78249

Road Runner Research, Ltd ( Site 0052), San Antonio

78411

Driscoll Children's Hospital ( Site 0025), Corpus Christi

78539

DHR Health Institute for Research and Development ( Site 0029), Edinburg

79106

Universitaetsklinikum Freiburg ( Site 0365), Freiburg im Breisgau

80045

Children's Hospital Colorado ( Site 0011), Aurora

80337

Dr. von Haunersches Kinderspital ( Site 0358), Munich

81545

München Klinik Harlaching ( Site 0351), Munich

83404

Clinical Research Prime ( Site 0046), Idaho Falls

84113

Intermountain - Primary Children's Hospital ( Site 0026), Salt Lake City

88996

Sabah Women and Children Hospital ( Site 0478), Kota Kinabalu

90110

Songklanagarind hospital-Department of Pediatrics ( Site 0776), Hat Yai

90220

FVR, Oulun rokotetutkimusklinikka ( Site 0303), Oulu

90806

Miller Children's & Women's Hospital Long Beach ( Site 0001), Long Beach

92868

Children's Hospital of Orange County ( Site 0047), Orange

96000

Hospital Sibu ( Site 0476), Sibu

98405

MultiCare Health System-Baker Center ( Site 0036), Tacoma

99202

Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004), Spokane

99204

Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030), Spokane

111411

Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230), Bogotá

229899

KK Women's and Children's Hospital-Department of Neonatology ( Site 0877), Singapore

760042

Clínica Imbanaco S.A.S ( Site 0229), Santiago de Cali

999077

Tuen Mun Hospital ( Site 0927), Tuenmen

8320325

Clínica Alemana de Santiago-Neonatology department ( Site 0207), Santiago

8380418

Hospital Roberto del Río-Infectología Pediátrica ( Site 0205), Santiago

8880465

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201), Santiago

08901

Rutgers University-Pediatric Clinical Research Center ( Site 0007), New Brunswick

T3B 6A8

Alberta Children's Hospital-Department of Pediatrics ( Site 0180), Calgary

B3K 6R8

Canadian Center for Vaccinology ( Site 0179), Halifax

H3T 1C5

CHU Sainte-Justine ( Site 0178), Montreal

050010

Fundación Hospitalaria San Vicente de Paúl ( Site 0233), Medellín

08001

Ciensalud Ips S A S ( Site 0235), Barranquilla

708 52

Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252), Ostrava

00290

MeVac - Meilahti Vaccine Research Center ( Site 0306), Helsinki

01307

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin ( Site 0363), Dresden

04103

Universitätsklinikum Leipzig-Neonatology ( Site 0354), Leipzig

115 27

Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 0852), Athens

Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854), Athens

124 62

ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855), Chaïdári

Unknown

Prince of Wales Hospital ( Site 0926), Shatin

Bajai Szent Rókus Kórház ( Site 0386), Baja

00165

Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427), Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426), Rome

813-0017

Fukuoka Children's Hospital ( Site 0452), Fukuoka

820-8505

Iizuka Hospital ( Site 0457), Iizuka

806-8501

Japan Community Healthcare Organization Kyushu Hospital ( Site 0454), Kitakyushu-shi

371-0811

Maebashi Red Cross Hospital ( Site 0451), Maebashi

311-4145

Ibaraki Children's Hospital ( Site 0458), Mito

173-8610

Nihon University Itabashi Hospital ( Site 0453), Itabashiku

422-8527

Shizuoka Saiseikai General Hospital ( Site 0456), Shizuoka

157-8535

National Center for Child Health and Development ( Site 0455), Tokyo

04530

Instituto Nacional de Pediatria ( Site 0506), Mexico City

0450

Oslo Universitetssykehus Ullevål ( Site 0551), Oslo

00935

UPR Medical Sciences Campus-Pediatrics ( Site 0626), San Juan

08916

Hospital Germans Trias i Pujol ( Site 0738), Badalona

08950

Hospital Sant Joan de Déu ( Site 0730), Esplugues de Llobregat

08195

Hospital Universitary General de Catalunya-Pediatrics ( Site 0737), Sant Cugat del Vallès

01030

cukurova universty ( Site 0805), Sarçam

06100

Ankara University Hospital Cebeci ( Site 0801), Ankara

06560

Gazi Universitesi ( Site 0806), Ankara

06800

Ankara Bilkent Şehir Hastanesi. ( Site 0807), Ankara

E11 1NR

Whipps Cross University Hospital ( Site 0846), London

SW17 0RE

St. George's Hospital ( Site 0845), London

G51 4TF

Queen Elizabeth University Hospital ( Site 0842), Glasgow

SE1 7EH

Evelina London Children's Hospital ( Site 0829), London

SO16 0YD

Southampton General Hospital ( Site 0826), Southampton

E1 1BB

Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844), London

OX3 9DU

The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827), Oxford

L12 2AP

Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843), Liverpool

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04938830 - Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) | Biotech Hunter | Biotech Hunter