Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

3,632

Participants

Timeline

Start Date

April 7, 2021

Primary Completion Date

July 9, 2024

Study Completion Date

July 9, 2024

Conditions
Respiratory Syncytial Virus Infection
Interventions
BIOLOGICAL

Clesrovimab

Clesrovimab solution

DRUG

Placebo

Placebo (0.9% sodium chloride \[NaCL\]) solution

Trial Locations (217)

1000

Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003), Brussels

University of the Philippines-Philippine General Hospital ( Site 3152), Manila

1100

Philippine Children s Medical Center ( Site 3154), Quezon City

1118

Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153), Quezon City

1200

Cliniques Universitaires Saint-Luc ( Site 2005), Brussels

2013

Baragwanath Hospital ( Site 2501), Johannesburg

2093

Empilweni Services and Research Unit ( Site 2504), Johannesburg

2650

Universitair Ziekenhuis Antwerpen ( Site 2001), Edegem

4013

Enhancing Care Foundation-DICRS ( Site 2506), Durban

5000

Odense University Hospital ( Site 2107), Odense

5004

SANATORIO DEL SALVADOR-Pediatria ( Site 1008), Córdoba

6534

Cabinet Médical Demeulemeester ( Site 2002), Gozée

7400

Regionshospitalet Herning ( Site 2105), Herning

7505

Tygerberg Hospital ( Site 2503), Cape Town

7700

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502), Cape Town

8800

AZ Delta ( Site 2004), Roeselare

9000

Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100), Aalborg

9301

University Of The Orange Free State ( Site 2507), Bloemfontein

9800

Regionshospitalet Nordjylland ( Site 2102), Hjørring

10330

Chulalongkorn University-Pediatrics ( Site 3252), Bangkok

10700

Siriraj Hospital ( Site 3251), Bangkok

10990

Hospital Pulau Pinang ( Site 3104), George Town

13011

Clinica Peruano Americana S.A. ( Site 1253), Trujillo

13620

Seoul National University Bundang Hospital-Pediatrics ( Site 3204), Seongnam

13700

Hospital Seberang Jaya ( Site 3107), Seberang Jaya

14033

CHU Caen ( Site 2212), Caen

14068

Hallym University Sacred Heart Hospital ( Site 3207), Anyang

15001

Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251), Lima

15213

UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043), Pittsburgh

15355

Korea University Ansan Hospital ( Site 3212), Ansan-si

15586

Hospital Raja Perempuan Zainab II ( Site 3106), Kota Bharu

16001

Asociacion Civil Selva Amazonica ( Site 1255), Iquitos

16148

CCP- Kid's Way ( Site 0017), Hermitage

20010

Children's National Hospital ( Site 0076), Washington D.C.

20016

MedStar Georgetown Pediatrics ( Site 0047), Washington D.C.

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310), Milan

20259

Centenario Hospital Miguel Hidalgo ( Site 1204), Aguascalientes

20520

FVR, Turun rokotetutkimusklinikka ( Site 2151), Turku

21431

The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209), Bupyeong-gu

22902

Pediatric Research of Charlottesville, LLC ( Site 0073), Charlottesville

25701

Marshall University School of Medicine and Medical Center ( Site 0064), Huntington

27103

Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093), Winston-Salem

28100

FVR, Porin rokotetutkimusklinikka ( Site 2156), Pori

29414

Coastal Pediatric Research ( Site 0013), Charleston

29607

Tribe Clinical Research, LLC ( Site 0015), Greenville

30341

Tekton Research ( Site 0080), Chamblee

31210

Meridian Clinical Research, LLC ( Site 0083), Macon

32040

Hospital Seri Manjung ( Site 3103), Seri Manjung

33000

Groupe Hospitalier Pellegrin ( Site 2218), Bordeaux

33030

Next Phase Research Alliance, LLC ( Site 0071), Homestead

33100

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160), Tampere

33142

Acevedo Clinical Research Associates ( Site 0002), Miami

34000

Hospital Taiping ( Site 3108), Taiping

35100

Ege University Medical Faculty ( Site 2553), Izmir

35128

Universita degli studi di Padova Patologia e TIN ( Site 2305), Padua

36303

Southeastern Pediatric Associates, P.A. ( Site 0008), Dothan

37660

Holston Medical Group ( Site 0040), Kingsport

38039

Erciyes University Medical Faculty-pediatric infection ( Site 2554), Kayseri

40002

Srinagarind Hospital. Khon Kaen University ( Site 3253), Muang

44121

Senders Pediatrics ( Site 0062), Cleveland

45414

Ohio Pediatric Research Association ( Site 0063), Dayton

49241

Pusan National University Hospital ( Site 3206), Busan

50139

A.O.Universitaria Meyer ( Site 2306), Florence

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 3254), Chiang Mai

52763

Hospital Angeles Lomas ( Site 1207), Huixquilucan

54449

Marshfield Clinic ( Site 0054), Marshfield

54907

Jeonbuk National University Hospital ( Site 3210), Jeonju

60100

FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155), Seinäjoki

66604

Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061), Topeka

67100

FVR, Kokkolan rokotetutkimusklinikka ( Site 2157), Kokkola

68504

Midwest Children's Health Research Institute, LLC ( Site 0044), Lincoln

68901

Meridian Clinical Research, LLC ( Site 0082), Hastings

70124

A.O. Policlinico Consorziale di Bari ( Site 2309), Bari

71037

ACC Pediatric Research ( Site 0067), Haughton

72401

Children's Clinic of Jonesboro, PA ( Site 0058), Jonesboro

72703

Northwest Arkansas Pediatric Clinic ( Site 0050), Fayetteville

75035

Javara - Privia Medical Group North Texas - Frisco ( Site 0086), Frisco

75605

DCOL Center for Clinical Research ( Site 0042), Longview

76550

FMC Science - Lampasas ( Site 0011), Lampasas

77065

DM Clinical Research ( Site 0005), Houston

77555

University of Texas Medical Branch at Galveston ( Site 0059), Galveston

78150

Centre Hospitalier de Versailles ( Site 2206), Le Chesnay

78229

University Health System- San Antonio ( Site 0048), San Antonio

78244

Private Practice - Dr. Etokhana ( Site 0089), San Antonio

78249

Road Runner Research, Ltd ( Site 0049), San Antonio

80045

Children's Hospital Colorado ( Site 0066), Aurora

80922

Optumcare Colorado Springs, LLC ( Site 0022), Colorado Springs

83404

Clinical Research Prime ( Site 0075), Idaho Falls

83686

Saltzer Medical Group ( Site 0004), Nampa

84037

Alliance for Multispecialty Research, LLC ( Site 0092), Kaysville

84041

Wee Care Pediatrics ( Site 0077), Layton

84067

Wee Care Pediatrics-Roy ( Site 0053), Roy

84075

Wee Care Pediatrics ( Site 0065), Syracuse

84095

Copperview Medical Center ( Site 0078), South Jordan

84107

Cottonwood Pediatrics ( Site 0032), Murray

84108

University of Utah School of Medicine ( Site 0006), Salt Lake City

88996

Sabah Womens & Childrens Hospital ( Site 3102), Kota Kinabalu

90110

Prince of Songkla University Faculty of Medicine ( Site 3255), Hat Yai

90220

FVR, Oulun rokotetutkimusklinikka ( Site 2158), Oulu

90806

Long Beach Memorial Medical Center ( Site 0014), Long Beach

91762

Orange County Research Institute ( Site 0057), Ontario

93637

Madera Family Medical Group ( Site 0046), Madera

96000

Hospital Sibu ( Site 3101), Sibu

98405

Multicare Institute For Research And Innovation ( Site 0045), Tacoma

99004

MultiCare Rockwood Cheney Clinic ( Site 0068), Cheney

99202

Multicare Health System Institute for Research and Innovation ( Site 0025), Spokane

100091

Peking University Third Hospital ( Site 3339), Beijing

116012

Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33, Dalian

201102

Children's Hospital of Fudan University ( Site 3361), Shanghai

210009

Zhongda Hospital Southeast University ( Site 3353), Nanjing

250001

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155), Chía

310006

The First People's Hospital of Hangzhou ( Site 3342), Hangzhou

315012

Ningbo Women and Children's Hospital ( Site 3314), Ningbo

330006

Jiangxi Provincial Children's Hospital ( Site 3313), Nanchang

330009

The Third Hospital of Nanchang ( Site 3325), Nanchang

337000

Jiangxi Pingxiang People's Hospital ( Site 3312), Pingxiang

361003

Xiamen Maternity and Child Health Care Hospital ( Site 3351), Xiamen

400065

The Children's Hospital of Chongqing Medical University ( Site 3333), Chongqing

402260

Jiangjin District Central Hospital ( Site 3319), Chongqing

410000

The Maternal and Child Health Hospital of Hunan Province ( Site 3334), Changsha

410005

Hunan Provincial People's Hospital ( Site 3355), Changsha

410008

Xiangya Hospital Central South University ( Site 3347), Changsha

415000

Changde First People's Hospital ( Site 3311), Changde

422000

Hunan Shaoyang No.1 People's Hospital ( Site 3345), Shaoyang

430000

Wuhan Children's Hospital ( Site 3329), Wuhan

430060

Renmin Hospital of Wuhan University ( Site 3316), Wuhan

472000

Sanmenxia Central Hospital ( Site 3360), Sanmenxia

500063

Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456), Brasov

510080

Guangdong Provincial People's Hospital ( Site 3341), Guangzhou

510150

The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348), Guangzhou

511400

Guangdong Maternity and Child Health Care Hospital ( Site 3340), Guangzhou

545006

Liuzhou People's Hospital ( Site 3364), Liuzhou

610091

Chengdu Women and Children Center Hospital ( Site 3332), Chengdu

700038

Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452), Iași

760001

Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159), Santiago de Cali

900591

Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458), Constanța

3525408

Rambam Medical Center ( Site 2352), Haifa

5265601

Chaim Sheba Medical Center ( Site 2353), Ramat Gan

8242238

Hospital La Florida ( Site 1104), Santiago

8380418

Hospital Roberto del Rio ( Site 1106), Santiago

8380453

Facultad Medicina Universidad de Chile ( Site 1105), Santiago

8410101

Soroka Medical Center ( Site 2351), Beersheba

8471844

Soroka University Medical Center Ramot Family health center ( Site 2354), Beersheba

8535700

Soroka University Medical Center Rahat Family health center ( Site 2355), Rahat

8880465

Hospital Padre Hurtado ( Site 1101), Santiago

03756

Dartmouth-Hitchcock Medical Center ( Site 0031), Lebanon

08901

Rutgers University-Pediatric Clinical Research Center ( Site 0055), New Brunswick

C1426BOS

Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001), Ciudad Autonoma de Buenos Aires

B7600FYH

Clinica del Nino y la Madre ( Site 1005), Mar de La Plata

C1425DND

SANATORIO MATER DEI ( Site 1010), Buenos Aires

X5000IIH

Clinica Privada del Sol S.A ( Site 1013), Córdoba

T3B 6A8

University of Calgary - Alberta Children Hospital ( Site 0504), Calgary

V6H 3N1

BC Women s Hospital and Health Centre ( Site 0506), Vancouver

B3K 6R8

Canadian Center for Vaccinology ( Site 0503), Halifax

L8M 1K7

Hamilton Medical Research Group ( Site 0509), Hamilton

H3T 1C5

CHU Sainte Justine ( Site 0502), Montreal

H9H 4Y6

McGill University Health Centre - Vaccine Study Centre ( Site 0500), Pierrefonds

G1E 7G9

CHU de Quebec Universite de Laval ( Site 0501), Québec

065000

Hebei Petro China Central Hospital ( Site 3365), Langfang

050035

Fourth Hospital of Hebei Medical University ( Site 3366), Shijiazhuang

041000

Linfen Central Hospital ( Site 3368), Linfen

041081

Linfen People's Hospital ( Site 3363), Linfen

044000

Yuncheng Central Hospital - Eastern Hospital ( Site 3318), Yuncheng

050036

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154), Medellín

054040

Sociedad Medica de Rionegro SOMER S.A. ( Site 1157), Rionegro

080020

Clinica de la Costa S.A.S. ( Site 1152), Barranquilla

02230

FVR, Espoon rokotetutkimusklinikka ( Site 2152), Espoo

00100

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159), Helsinki

00930

FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153), Helsinki

04400

FVR, Järvenpään rokotetutkimusklinikka ( Site 2154), Järvenpää

00168

Policlinico Universitario Gemelli ( Site 2301), Rome

371-0811

Maebashi Red Cross Hospital ( Site 3057), Maebashi

216-8511

St. Marianna University School of Medicine Hospital ( Site 3060), Kawasaki

222-0036

JOHAS Yokohama Rosai Hospital ( Site 3058), Yokohama

Unknown

National Hospital Organization Beppu Medical Center ( Site 3063), Beppu

362-8588

Ageo Central General Hospital ( Site 3051), Ageo

683-8504

Tottori University Hospital ( Site 3053), Yonago

910-0833

Fukui Aiiku Hospital ( Site 3056), Fukui

918-8503

Fukui-ken Saiseikai Hospital ( Site 3064), Fukui

336-8522

Saitama City Hospital ( Site 3055), Saitama

424-8636

Shizuoka City Shimizu Hospital ( Site 3061), Shizuoka

104-8560

St.Luke's International Hospital ( Site 3062), Tokyo

142-8666

Showa University Hospital ( Site 3059), Tokyo

06760

CAIMED Investigación en Salud S.A de C.V ( Site 1209), Mexico City

04530

Instituto Nacional de Pediatria ( Site 1202), Mexico City

LIMA 36

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252), Lima

60-129

Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412), Poznan

85-048

IN VIVO ( Site 2401), Bydgoszcz

31-411

Centrum Medyczne PROMED ( Site 2432), Krakow

33-100

Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403), Tarnów

55-100

Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409), Trzebnica

50-368

Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440), Wroclaw

20-093

Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404), Lublin

21-010

NZOZ Salmed ( Site 2433), Łęczna

02-972

MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426), Mazowieckie

00-315

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435), Warsaw

00-728

WIP Warsaw IBD Point Profesor Kierkus ( Site 2441), Warsaw

01-809

Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425), Warsaw

01-868

Centrum Medyczne Pratia Warszawa ( Site 2438), Warsaw

80-214

Uniwersyteckie Centrum Kliniczne ( Site 2437), Gdansk

43-100

Szpital Miejski w Tychach ( Site 2442), Tychy

91-347

Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423), Lodz

011171

"Spitalul Clinic Filantropia Clinica Obstetrica-Ginecologie ( Site 2451)", Bucharest

0002

Steve Biko Academic Hospital ( Site 2505), Pretoria

06973

Chungang University Hospital ( Site 3211), Dongjak-gu

03080

Seoul National University Hospital ( Site 3203), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 3201), Seoul

06351

Samsung Medical Center ( Site 3202), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208), Seoul

01330

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555), Adana

06560

Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552), Ankara

06590

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551), Ankara

BS2 8AE

UH Bristol Education Centre ( Site 2607), Bristol

SW17 0QT

St. Georges University Hospital NHS Foundation Trust ( Site 2601), London

BT12 6BB

Royal Maternity Hospital ( Site 2602), Belfast

OX3 9DU

Oxford University Hospital NHS Foundation Trust ( Site 2604), Oxford

L12 2AP

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606), Liverpool

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04767373 - Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004) | Biotech Hunter | Biotech Hunter