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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infection
• Interventions: Biological: Clesrovimab; Drug: Placebo

• Registration Number: NCT04767373
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-04-07
• Status Verified: 2024-07
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3632

Inclusion Criteria

• Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
• For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
• For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
• For participants in South Korea only: Weighs ≥2 kg

Key

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Exclusion Criteria

• Is recommended to receive palivizumab per local guidelines or professional society recommendations.
• Has known hypersensitivity to any component of clesrovimab
• Has a bleeding disorder contraindicating IM administration
• Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
• Has received any vaccine or monoclonal antibody for the prevention of RSV
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clesrovimab	Clesrovimab	Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
Placebo	Placebo	Participants receive a single IM administration of placebo on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with fever	From Day 1 (postdose) to Day 5	Fever is defined as as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). The percentage of participants with fever will be reported.
Percentage of participants with RSV-associated MALRI	From Day 1 (postdose) to Day 150	Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample.
Percentage of participants with solicited injection-site adverse events (AEs)	From Day 1 (postdose) to Day 5	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs (i.e., redness/erythema, swelling, and pain/tenderness) will be reported.
Percentage of participants with solicited systemic AEs	From Day 1 (postdose) to Day 5	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs (i.e., irritability, drowsiness, and appetite lost) will be reported.
Percentage of participants with rash AESI	From Day 1 (postdose) to Day 42	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with rash will be reported.
Percentage of participants with ≥1 nonserious AE	From Day 1 (postdose) to Day 42	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)	From Day 1 (postdose) to Day 42	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with anaphylaxis/hypersensitivity will be reported.
Percentage of participants with serious adverse events (SAEs)	Up to Day 515	An SAE is any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with SAEs will be reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with RSV-associated hospitalization	From Day 1 (postdose) to Day 150	RSV-associated hospitalization is defined as a hospital admission for respiratory illness AND RSV-positive RT-PCR nasopharyngeal sample.
Percentage of participants with RSV-associated MALRI	From Day 1 (postdose) to Day 180	Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive RT-PCR nasopharyngeal sample.

Trial Locations

Locations (217)

Children's Clinic of Jonesboro, PA ( Site 0058); 🇺🇸 Jonesboro, Arkansas, United States

Senders Pediatrics ( Site 0062); 🇺🇸 Cleveland, Ohio, United States

UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043); 🇺🇸 Pittsburgh, Pennsylvania, United States

Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412); 🇵🇱 Poznan, Wielkopolskie, Poland

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252); 🇵🇪 Lima, Peru

FVR, Oulun rokotetutkimusklinikka ( Site 2158); 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

CHU Caen ( Site 2212); 🇫🇷 Caen, Calvados, France

FVR, Järvenpään rokotetutkimusklinikka ( Site 2154); 🇫🇮 Järvenpää, Uusimaa, Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159); 🇫🇮 Helsinki, Uusimaa, Finland

Hospital Raja Perempuan Zainab II ( Site 3106); 🇲🇾 Kota Bahru, Kelantan, Malaysia

FVR, Espoon rokotetutkimusklinikka ( Site 2152); 🇫🇮 Espoo, Uusimaa, Finland

Hospital La Florida ( Site 1104); 🇨🇱 Santiago, Region M. De Santiago, Chile

Hospital Seberang Jaya ( Site 3107); 🇲🇾 Seberang Jaya, Pulau Pinang, Malaysia

University of the Philippines-Philippine General Hospital ( Site 3152); 🇵🇭 Manila, National Capital Region, Philippines

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502); 🇿🇦 Cape Town, Western Cape, South Africa

Royal Maternity Hospital ( Site 2602); 🇬🇧 Belfast, Northern Ireland, United Kingdom

Tygerberg Hospital ( Site 2503); 🇿🇦 Cape Town, Western Cape, South Africa

Acevedo Clinical Research Associates ( Site 0002); 🇺🇸 Miami, Florida, United States

Road Runner Research, Ltd ( Site 0049); 🇺🇸 San Antonio, Texas, United States

Meridian Clinical Research, LLC ( Site 0083); 🇺🇸 Macon, Georgia, United States

Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093); 🇺🇸 Winston-Salem, North Carolina, United States

Next Phase Research Alliance, LLC ( Site 0071); 🇺🇸 Homestead, Florida, United States

Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061); 🇺🇸 Topeka, Kansas, United States

Dartmouth-Hitchcock Medical Center ( Site 0031); 🇺🇸 Lebanon, New Hampshire, United States

Orange County Research Institute ( Site 0057); 🇺🇸 Ontario, California, United States

Children's National Hospital ( Site 0076); 🇺🇸 Washington, District of Columbia, United States

Ohio Pediatric Research Association ( Site 0063); 🇺🇸 Dayton, Ohio, United States

Long Beach Memorial Medical Center ( Site 0014); 🇺🇸 Long Beach, California, United States

Children's Hospital Colorado ( Site 0066); 🇺🇸 Aurora, Colorado, United States

Meridian Clinical Research, LLC ( Site 0082); 🇺🇸 Hastings, Nebraska, United States

MedStar Georgetown Pediatrics ( Site 0047); 🇺🇸 Washington, District of Columbia, United States

Madera Family Medical Group ( Site 0046); 🇺🇸 Madera, California, United States

Clinical Research Prime ( Site 0075); 🇺🇸 Idaho Falls, Idaho, United States

Saltzer Medical Group ( Site 0004); 🇺🇸 Nampa, Idaho, United States

Tribe Clinical Research, LLC ( Site 0015); 🇺🇸 Greenville, South Carolina, United States

Optumcare Colorado Springs, LLC ( Site 0022); 🇺🇸 Colorado Springs, Colorado, United States

Northwest Arkansas Pediatric Clinic ( Site 0050); 🇺🇸 Fayetteville, Arkansas, United States

ACC Pediatric Research ( Site 0067); 🇺🇸 Haughton, Louisiana, United States

CCP- Kid's Way ( Site 0017); 🇺🇸 Hermitage, Pennsylvania, United States

Wee Care Pediatrics ( Site 0077); 🇺🇸 Layton, Utah, United States

Facultad Medicina Universidad de Chile ( Site 1105); 🇨🇱 Santiago, Region M. De Santiago, Chile

University Health System- San Antonio ( Site 0048); 🇺🇸 San Antonio, Texas, United States

CHU Sainte Justine ( Site 0502); 🇨🇦 Montreal, Quebec, Canada

BC Women s Hospital and Health Centre ( Site 0506); 🇨🇦 Vancouver, British Columbia, Canada

FMC Science - Lampasas ( Site 0011); 🇺🇸 Lampasas, Texas, United States

Wee Care Pediatrics ( Site 0065); 🇺🇸 Syracuse, Utah, United States

McGill University Health Centre - Vaccine Study Centre ( Site 0500); 🇨🇦 Pierrefonds, Quebec, Canada

Wee Care Pediatrics-Roy ( Site 0053); 🇺🇸 Roy, Utah, United States

Clinica Privada del Sol S.A ( Site 1013); 🇦🇷 Cordoba, Argentina

Canadian Center for Vaccinology ( Site 0503); 🇨🇦 Halifax, Nova Scotia, Canada

Holston Medical Group ( Site 0040); 🇺🇸 Kingsport, Tennessee, United States

University of Texas Medical Branch at Galveston ( Site 0059); 🇺🇸 Galveston, Texas, United States

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154); 🇨🇴 Medellin, Antioquia, Colombia

DM Clinical Research ( Site 0005); 🇺🇸 Houston, Texas, United States

University of Utah School of Medicine ( Site 0006); 🇺🇸 Salt Lake City, Utah, United States

Marshfield Clinic ( Site 0054); 🇺🇸 Marshfield, Wisconsin, United States

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

Hamilton Medical Research Group ( Site 0509); 🇨🇦 Hamilton, Ontario, Canada

Hospital Padre Hurtado ( Site 1101); 🇨🇱 Santiago, Region M. De Santiago, Chile

Private Practice - Dr. Etokhana ( Site 0089); 🇺🇸 San Antonio, Texas, United States

FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155); 🇫🇮 Seinajoki, Sodra Osterbotten, Finland

Policlinico Universitario Gemelli ( Site 2301); 🇮🇹 Rome, Roma, Italy

Cottonwood Pediatrics ( Site 0032); 🇺🇸 Murray, Utah, United States

Soroka Medical Center ( Site 2351); 🇮🇱 Beer-Sheva, Israel

SANATORIO MATER DEI ( Site 1010); 🇦🇷 Buenos Aires, Argentina

University of Calgary - Alberta Children Hospital ( Site 0504); 🇨🇦 Calgary, Alberta, Canada

Marshall University School of Medicine and Medical Center ( Site 0064); 🇺🇸 Huntington, West Virginia, United States

MultiCare Rockwood Cheney Clinic ( Site 0068); 🇺🇸 Cheney, Washington, United States

Pediatric Research of Charlottesville, LLC ( Site 0073); 🇺🇸 Charlottesville, Virginia, United States

Sociedad Medica de Rionegro SOMER S.A. ( Site 1157); 🇨🇴 Rionegro, Antioquia, Colombia

Universitair Ziekenhuis Antwerpen ( Site 2001); 🇧🇪 Edegem, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc ( Site 2005); 🇧🇪 Bruxelles, Bruxelles-Capitale, Region De, Belgium

Copperview Medical Center ( Site 0078); 🇺🇸 South Jordan, Utah, United States

SANATORIO DEL SALVADOR-Pediatria ( Site 1008); 🇦🇷 Córdoba, Cordoba, Argentina

Clinica del Nino y la Madre ( Site 1005); 🇦🇷 Mar De La Plata, Buenos Aires, Argentina

Alliance for Multispecialty Research, LLC ( Site 0092); 🇺🇸 Kaysville, Utah, United States

Hospital Roberto del Rio ( Site 1106); 🇨🇱 Santiago, Region M. De Santiago, Chile

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160); 🇫🇮 Tampere, Pirkanmaa, Finland

FVR, Kokkolan rokotetutkimusklinikka ( Site 2157); 🇫🇮 Kokkola, Mellersta Osterbotten, Finland

Groupe Hospitalier Pellegrin ( Site 2218); 🇫🇷 Bordeaux, Gironde, France

A.O.Universitaria Meyer ( Site 2306); 🇮🇹 Firenze, Toscana, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310); 🇮🇹 Milano, Italy

Seoul National University Bundang Hospital-Pediatrics ( Site 3204); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159); 🇨🇴 Cali, Valle Del Cauca, Colombia

FVR, Porin rokotetutkimusklinikka ( Site 2156); 🇫🇮 Pori, Satakunta, Finland

JOHAS Yokohama Rosai Hospital ( Site 3058); 🇯🇵 Yokohama, Kanagawa, Japan

FVR, Turun rokotetutkimusklinikka ( Site 2151); 🇫🇮 Turku, Varsinais-Suomi, Finland

Centre Hospitalier de Versailles ( Site 2206); 🇫🇷 Le Chesnay, Yvelines, France

Hospital Pulau Pinang ( Site 3104); 🇲🇾 Georgetown, Pulau Pinang, Malaysia

FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153); 🇫🇮 Helsinki, Uusimaa, Finland

A.O. Policlinico Consorziale di Bari ( Site 2309); 🇮🇹 Bari, Italy

Ageo Central General Hospital ( Site 3051); 🇯🇵 Ageo, Saitama, Japan

Tottori University Hospital ( Site 3053); 🇯🇵 Yonago, Tottori, Japan

Soroka University Medical Center Ramot Family health center ( Site 2354); 🇮🇱 Be'er Sheva, Israel

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155); 🇨🇴 Chía, Cundinamarca, Colombia

Seoul National University Hospital ( Site 3203); 🇰🇷 Seoul, Korea, Republic of

Chaim Sheba Medical Center ( Site 2353); 🇮🇱 Ramat Gan, Israel

Pusan National University Hospital ( Site 3206); 🇰🇷 Busan, Pusan-Kwangyokshi, Korea, Republic of

Jeonbuk National University Hospital ( Site 3210); 🇰🇷 Jeonju-si, Jeonrabugdo, Korea, Republic of

Clinica de la Costa S.A.S. ( Site 1152); 🇨🇴 Barranquilla, Atlantico, Colombia

Instituto Nacional de Pediatria ( Site 1202); 🇲🇽 Mexico City, Mexico

Maharaj Nakorn Chiang Mai Hospital ( Site 3254); 🇹🇭 Chiang Mai, Thailand

Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404); 🇵🇱 Lublin, Lubelskie, Poland

Centrum Medyczne Pratia Warszawa ( Site 2438); 🇵🇱 Warszawa, Mazowieckie, Poland

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551); 🇹🇷 Ankara, Turkey

St. Marianna University School of Medicine Hospital ( Site 3060); 🇯🇵 Kawasaki, Kanagawa, Japan

Baragwanath Hospital ( Site 2501); 🇿🇦 Johannesburg, Gauteng, South Africa

Hospital Taiping ( Site 3108); 🇲🇾 Taiping, Perak, Malaysia

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

Hospital Seri Manjung ( Site 3103); 🇲🇾 Seri Manjung, Perak, Malaysia

Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251); 🇵🇪 Lima, Peru

Fukui Aiiku Hospital ( Site 3056); 🇯🇵 Fukui, Japan

Severance Hospital Yonsei University Health System ( Site 3201); 🇰🇷 Seoul, Korea, Republic of

Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153); 🇵🇭 Quezon City, National Capital Region, Philippines

Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458); 🇷🇴 Constanta, Romania

Siriraj Hospital ( Site 3251); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Oxford University Hospital NHS Foundation Trust ( Site 2604); 🇬🇧 Oxford, Oxfordshire, United Kingdom

NZOZ Salmed ( Site 2433); 🇵🇱 Leczna, Lubelskie, Poland

Szpital Miejski w Tychach ( Site 2442); 🇵🇱 Tychy, Slaskie, Poland

Hospital Sibu ( Site 3101); 🇲🇾 Sibu, Sarawak, Malaysia

Srinagarind Hospital. Khon Kaen University ( Site 3253); 🇹🇭 Muang, Khon Kaen, Thailand

Centenario Hospital Miguel Hidalgo ( Site 1204); 🇲🇽 Aguascalientes, Mexico

Hospital Angeles Lomas ( Site 1207); 🇲🇽 Huixquilucan, Mexico

Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452); 🇷🇴 Iasi, Romania

Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423); 🇵🇱 Lodz, Lodzkie, Poland

Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425); 🇵🇱 Warszawa, Mazowieckie, Poland

Uniwersyteckie Centrum Kliniczne ( Site 2437); 🇵🇱 Gdansk, Pomorskie, Poland

Clinica Peruano Americana S.A. ( Site 1253); 🇵🇪 Trujillo, La Libertad, Peru

UH Bristol Education Centre ( Site 2607); 🇬🇧 Bristol, Bristol, City Of, United Kingdom

Enhancing Care Foundation-DICRS ( Site 2506); 🇿🇦 Durban, Kwazulu-Natal, South Africa

Philippine Children s Medical Center ( Site 3154); 🇵🇭 Quezon City, National Capital Region, Philippines

Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456); 🇷🇴 Brasov, Romania

Chulalongkorn University-Pediatrics ( Site 3252); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409); 🇵🇱 Trzebnica, Dolnoslaskie, Poland

MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426); 🇵🇱 Mazowieckie, Poland

Empilweni Services and Research Unit ( Site 2504); 🇿🇦 Johannesburg, Gauteng, South Africa

Prince of Songkla University Faculty of Medicine ( Site 3255); 🇹🇭 Hat Yai, Songkhla, Thailand

Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451); 🇷🇴 Bucuresti, Romania

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555); 🇹🇷 Adana, Turkey

Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440); 🇵🇱 Wrocław, Dolnoslaskie, Poland

Guangdong Provincial People's Hospital ( Site 3341); 🇨🇳 Guangzhou, Guangdong, China

Guangdong Maternity and Child Health Care Hospital ( Site 3340); 🇨🇳 Guangzhou, Guangdong, China

Peking University Third Hospital ( Site 3339); 🇨🇳 Beijing, Beijing, China

The Children's Hospital of Chongqing Medical University ( Site 3333); 🇨🇳 Chongqing, Chongqing, China

Jiangjin District Central Hospital ( Site 3319); 🇨🇳 Chongqing, Chongqing, China

Xiamen Maternity and Child Health Care Hospital ( Site 3351); 🇨🇳 Xiamen, Fujian, China

Liuzhou People's Hospital ( Site 3364); 🇨🇳 Liuzhou, Guangxi, China

Hebei Petro China Central Hospital ( Site 3365); 🇨🇳 Langfang, Hebei, China

Fourth Hospital of Hebei Medical University ( Site 3366); 🇨🇳 Shijiazhuang, Hebei, China

Renmin Hospital of Wuhan University ( Site 3316); 🇨🇳 Wuhan, Hubei, China

Wuhan Children's Hospital ( Site 3329); 🇨🇳 Wuhan, Hubei, China

Sanmenxia Central Hospital ( Site 3360); 🇨🇳 Sanmenxia, Henan, China

Changde First People's Hospital ( Site 3311); 🇨🇳 Changde, Hunan, China

Hunan Provincial People's Hospital ( Site 3355); 🇨🇳 Changsha, Hunan, China

Xiangya Hospital Central South University ( Site 3347); 🇨🇳 Changsha, Hunan, China

Zhongda Hospital Southeast University ( Site 3353); 🇨🇳 Nanjing, Jiangsu, China

Hunan Shaoyang No.1 People's Hospital ( Site 3345); 🇨🇳 Shaoyang, Hunan, China

Children's Hospital of Fudan University ( Site 3361); 🇨🇳 Shanghai, Shanghai, China

Jiangxi Provincial Children's Hospital ( Site 3313); 🇨🇳 Nanchang, Jiangxi, China

The Third Hospital of Nanchang ( Site 3325); 🇨🇳 Nanchang, Jiangxi, China

Jiangxi Pingxiang People's Hospital ( Site 3312); 🇨🇳 Pingxiang, Jiangxi, China

Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33; 🇨🇳 Dalian, Liaoning, China

Linfen Central Hospital ( Site 3368); 🇨🇳 Linfen, Shanxi, China

Linfen People's Hospital ( Site 3363); 🇨🇳 Linfen, Shanxi, China

Yuncheng Central Hospital - Eastern Hospital ( Site 3318); 🇨🇳 Yuncheng Shi, Shanxi, China

Chengdu Women and Children Center Hospital ( Site 3332); 🇨🇳 Chengdu, Sichuan, China

The First People's Hospital of Hangzhou ( Site 3342); 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Women and Children's Hospital ( Site 3314); 🇨🇳 Ningbo, Zhejiang, China

Regionshospitalet Herning ( Site 2105); 🇩🇰 Herning, Midtjylland, Denmark

Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100); 🇩🇰 Aalborg, Nordjylland, Denmark

Regionshospitalet Nordjylland ( Site 2102); 🇩🇰 Hjoerring, Nordjylland, Denmark

Odense University Hospital ( Site 2107); 🇩🇰 Odense, Syddanmark, Denmark

Universita degli studi di Padova Patologia e TIN ( Site 2305); 🇮🇹 Padova, Veneto, Italy

St. Georges University Hospital NHS Foundation Trust ( Site 2601); 🇬🇧 London, London, City Of, United Kingdom

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606); 🇬🇧 Liverpool, United Kingdom

Erciyes University Medical Faculty-pediatric infection ( Site 2554); 🇹🇷 Kayseri, Turkey

Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552); 🇹🇷 Ankara, Turkey

Showa University Hospital ( Site 3059); 🇯🇵 Tokyo, Japan

Saitama City Hospital ( Site 3055); 🇯🇵 Saitama, Japan

Shizuoka City Shimizu Hospital ( Site 3061); 🇯🇵 Shizuoka, Japan

Steve Biko Academic Hospital ( Site 2505); 🇿🇦 Pretoria, Gauteng, South Africa

Samsung Medical Center ( Site 3202); 🇰🇷 Seoul, Korea, Republic of

Chungang University Hospital ( Site 3211); 🇰🇷 Dongjak-gu, Seoul, Korea, Republic of

Southeastern Pediatric Associates, P.A. ( Site 0008); 🇺🇸 Dothan, Alabama, United States

Midwest Children's Health Research Institute, LLC ( Site 0044); 🇺🇸 Lincoln, Nebraska, United States

Tekton Research ( Site 0080); 🇺🇸 Chamblee, Georgia, United States

Rutgers University-Pediatric Clinical Research Center ( Site 0055); 🇺🇸 New Brunswick, New Jersey, United States

Javara - Privia Medical Group North Texas - Frisco ( Site 0086); 🇺🇸 Frisco, Texas, United States

Coastal Pediatric Research ( Site 0013); 🇺🇸 Charleston, South Carolina, United States

DCOL Center for Clinical Research ( Site 0042); 🇺🇸 Longview, Texas, United States

Multicare Health System Institute for Research and Innovation ( Site 0025); 🇺🇸 Spokane, Washington, United States

Cabinet Médical Demeulemeester ( Site 2002); 🇧🇪 Gozée, Wallonne, Region, Belgium

Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003); 🇧🇪 Brussels, Bruxelles-Capitale, Region De, Belgium

CHU de Quebec Universite de Laval ( Site 0501); 🇨🇦 Quebec, Canada

The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348); 🇨🇳 Guangzhou, Guangdong, China

The Maternal and Child Health Hospital of Hunan Province ( Site 3334); 🇨🇳 Changsha, Hunan, China

Rambam Medical Center ( Site 2352); 🇮🇱 Haifa, Israel

Soroka University Medical Center Rahat Family health center ( Site 2355); 🇮🇱 Rahat, Israel

Maebashi Red Cross Hospital ( Site 3057); 🇯🇵 Maebashi, Gunma, Japan

National Hospital Organization Beppu Medical Center ( Site 3063); 🇯🇵 Beppu, Oita, Japan

Fukui-ken Saiseikai Hospital ( Site 3064); 🇯🇵 Fukui, Japan

St.Luke's International Hospital ( Site 3062); 🇯🇵 Tokyo, Japan

Korea University Ansan Hospital ( Site 3212); 🇰🇷 Ansan-si, Kyonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital ( Site 3207); 🇰🇷 Anyang, Kyonggi-do, Korea, Republic of

CAIMED Investigación en Salud S.A de C.V ( Site 1209); 🇲🇽 Mexico, Distrito Federal, Mexico

Centrum Medyczne PROMED ( Site 2432); 🇵🇱 Krakow, Malopolskie, Poland

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435); 🇵🇱 Warszawa, Mazowieckie, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403); 🇵🇱 Tarnow, Malopolskie, Poland

Ege University Medical Faculty ( Site 2553); 🇹🇷 Izmir, Turkey

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

IN VIVO ( Site 2401); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

WIP Warsaw IBD Point Profesor Kierkus ( Site 2441); 🇵🇱 Warsaw, Mazowieckie, Poland

AZ Delta ( Site 2004); 🇧🇪 Roeselare, West-Vlaanderen, Belgium

Multicare Institute For Research And Innovation ( Site 0045); 🇺🇸 Tacoma, Washington, United States

Sabah Womens & Childrens Hospital ( Site 3102); 🇲🇾 Kota Kinabalu, Sabah, Malaysia

Asociacion Civil Selva Amazonica ( Site 1255); 🇵🇪 Iquitos, Loreto, Peru

University Of The Orange Free State ( Site 2507); 🇿🇦 Bloemfontein, Free State, South Africa