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

Primary Purpose

Respiratory Syncytial Virus Infection

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Clesrovimab
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infection

Eligibility Criteria

undefined - 1 Year (Child)All SexesAccepts Healthy Volunteers

Key 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 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

Sites / Locations

  • Southeastern Pediatric Associates, P.A. ( Site 0008)
  • Northwest Arkansas Pediatric Clinic ( Site 0050)
  • Children's Clinic of Jonesboro, PA ( Site 0058)
  • Long Beach Memorial Medical Center ( Site 0014)
  • Madera Family Medical Group ( Site 0046)
  • Orange County Research Institute ( Site 0057)
  • Children's Hospital Colorado ( Site 0066)
  • Optumcare Colorado Springs, LLC ( Site 0022)
  • Children's National Hospital ( Site 0076)
  • MedStar Georgetown Pediatrics ( Site 0047)
  • Next Phase Research Alliance, LLC ( Site 0071)
  • Acevedo Clinical Research Associates ( Site 0002)
  • Tekton Research ( Site 0080)
  • Meridian Clinical Research, LLC ( Site 0083)
  • Clinical Research Prime ( Site 0075)
  • Saltzer Medical Group ( Site 0004)
  • Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)
  • ACC Pediatric Research ( Site 0067)
  • Meridian Clinical Research, LLC ( Site 0082)
  • Midwest Children's Health Research Institute, LLC ( Site 0044)
  • Dartmouth-Hitchcock Medical Center ( Site 0031)
  • Rutgers University-Pediatric Clinical Research Center ( Site 0055)
  • Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)
  • Senders Pediatrics ( Site 0062)
  • Ohio Pediatric Research Association ( Site 0063)
  • CCP- Kid's Way ( Site 0017)
  • UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)
  • Coastal Pediatric Research ( Site 0013)
  • Tribe Clinical Research, LLC ( Site 0015)
  • Holston Medical Group ( Site 0040)
  • Javara - Privia Medical Group North Texas - Frisco ( Site 0086)
  • University of Texas Medical Branch at Galveston ( Site 0059)
  • DM Clinical Research ( Site 0005)
  • FMC Science - Lampasas ( Site 0011)
  • DCOL Center for Clinical Research ( Site 0042)
  • University Health System- San Antonio ( Site 0048)
  • Private Practice - Dr. Etokhana ( Site 0089)
  • Road Runner Research, Ltd ( Site 0049)
  • Alliance for Multispecialty Research, LLC ( Site 0092)
  • Wee Care Pediatrics ( Site 0077)
  • Cottonwood Pediatrics ( Site 0032)
  • Wee Care Pediatrics-Roy ( Site 0053)
  • University of Utah School of Medicine ( Site 0006)
  • Copperview Medical Center ( Site 0078)
  • Wee Care Pediatrics ( Site 0065)
  • Pediatric Research of Charlottesville, LLC ( Site 0073)
  • MultiCare Rockwood Cheney Clinic ( Site 0068)
  • Multicare Health System Institute for Research and Innovation ( Site 0025)
  • Multicare Institute For Research And Innovation ( Site 0045)
  • Marshall University School of Medicine and Medical Center ( Site 0064)
  • Marshfield Clinic ( Site 0054)
  • Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)
  • Clinica del Nino y la Madre ( Site 1005)
  • SANATORIO DEL SALVADOR-Pediatria ( Site 1008)
  • SANATORIO MATER DEI ( Site 1010)
  • Clinica Privada del Sol S.A ( Site 1013)
  • Universitair Ziekenhuis Antwerpen ( Site 2001)
  • Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)
  • Cliniques Universitaires Saint-Luc ( Site 2005)
  • Cabinet Médical Demeulemeester ( Site 2002)
  • AZ Delta ( Site 2004)
  • University of Calgary - Alberta Children Hospital ( Site 0504)
  • BC Women s Hospital and Health Centre ( Site 0506)
  • Canadian Center for Vaccinology ( Site 0503)
  • Hamilton Medical Research Group ( Site 0509)
  • CHU Sainte Justine ( Site 0502)
  • McGill University Health Centre - Vaccine Study Centre ( Site 0500)
  • CHU de Quebec Universite de Laval ( Site 0501)
  • Hospital La Florida ( Site 1104)
  • Hospital Roberto del Rio ( Site 1106)
  • Facultad Medicina Universidad de Chile ( Site 1105)
  • Hospital Padre Hurtado ( Site 1101)
  • Peking University Third Hospital ( Site 3339)
  • The Children's Hospital of Chongqing Medical University ( Site 3333)
  • Jiangjin District Central Hospital ( Site 3319)
  • Xiamen Maternity and Child Health Care Hospital ( Site 3351)
  • Guangdong Provincial People's Hospital ( Site 3341)
  • The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)
  • Guangdong Maternity and Child Health Care Hospital ( Site 3340)
  • Liuzhou People's Hospital ( Site 3364)
  • Hebei Petro China Central Hospital ( Site 3365)
  • Fourth Hospital of Hebei Medical University ( Site 3366)
  • Sanmenxia Central Hospital ( Site 3360)
  • Wuhan Children's Hospital ( Site 3329)
  • Renmin Hospital of Wuhan University ( Site 3316)
  • Changde First People's Hospital ( Site 3311)
  • The Maternal and Child Health Hospital of Hunan Province ( Site 3334)
  • Hunan Provincial People's Hospital ( Site 3355)
  • Xiangya Hospital Central South University ( Site 3347)
  • Hunan Shaoyang No.1 People's Hospital ( Site 3345)
  • Zhongda Hospital Southeast University ( Site 3353)
  • Jiangxi Provincial Children's Hospital ( Site 3313)
  • The Third Hospital of Nanchang ( Site 3325)
  • Jiangxi Pingxiang People's Hospital ( Site 3312)
  • Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33
  • Children's Hospital of Fudan University ( Site 3361)
  • Linfen Central Hospital ( Site 3368)
  • Linfen People's Hospital ( Site 3363)
  • Yuncheng Central Hospital - Eastern Hospital ( Site 3318)
  • Chengdu Women and Children Center Hospital ( Site 3332)
  • The First People's Hospital of Hangzhou ( Site 3342)
  • Ningbo Women and Children's Hospital ( Site 3314)
  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)
  • Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)
  • Clinica de la Costa S.A.S. ( Site 1152)
  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)
  • Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)
  • Regionshospitalet Herning ( Site 2105)
  • Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)
  • Regionshospitalet Nordjylland ( Site 2102)
  • Odense University Hospital ( Site 2107)
  • FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)
  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)
  • FVR, Oulun rokotetutkimusklinikka ( Site 2158)
  • FVR, Porin rokotetutkimusklinikka ( Site 2156)
  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)
  • FVR, Espoon rokotetutkimusklinikka ( Site 2152)
  • FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)
  • FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)
  • FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)
  • FVR, Turun rokotetutkimusklinikka ( Site 2151)
  • CHU Caen ( Site 2212)
  • Groupe Hospitalier Pellegrin ( Site 2218)
  • Centre Hospitalier de Versailles ( Site 2206)
  • Soroka University Medical Center Ramot Family health center ( Site 2354)
  • Soroka Medical Center ( Site 2351)
  • Rambam Medical Center ( Site 2352)
  • Soroka University Medical Center Rahat Family health center ( Site 2355)
  • Chaim Sheba Medical Center ( Site 2353)
  • Policlinico Universitario Gemelli ( Site 2301)
  • A.O.Universitaria Meyer ( Site 2306)
  • Universita degli studi di Padova Patologia e TIN ( Site 2305)
  • A.O. Policlinico Consorziale di Bari ( Site 2309)
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)
  • Maebashi Red Cross Hospital ( Site 3057)
  • St. Marianna University School of Medicine Hospital ( Site 3060)
  • JOHAS Yokohama Rosai Hospital ( Site 3058)
  • National Hospital Organization Beppu Medical Center ( Site 3063)
  • Ageo Central General Hospital ( Site 3051)
  • Tottori University Hospital ( Site 3053)
  • Fukui Aiiku Hospital ( Site 3056)
  • Fukui-ken Saiseikai Hospital ( Site 3064)
  • Saitama City Hospital ( Site 3055)
  • Shizuoka City Shimizu Hospital ( Site 3061)
  • St.Luke's International Hospital ( Site 3062)
  • Showa University Hospital ( Site 3059)
  • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)
  • Jeonbuk National University Hospital ( Site 3210)
  • Korea University Ansan Hospital ( Site 3212)
  • Hallym University Sacred Heart Hospital ( Site 3207)
  • Seoul National University Bundang Hospital-Pediatrics ( Site 3204)
  • Pusan National University Hospital ( Site 3206)
  • Chungang University Hospital ( Site 3211)
  • Seoul National University Hospital ( Site 3203)
  • Severance Hospital Yonsei University Health System ( Site 3201)
  • Samsung Medical Center ( Site 3202)
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)
  • Hospital Raja Perempuan Zainab II ( Site 3106)
  • Hospital Seri Manjung ( Site 3103)
  • Hospital Taiping ( Site 3108)
  • Hospital Pulau Pinang ( Site 3104)
  • Hospital Seberang Jaya ( Site 3107)
  • Sabah Womens & Childrens Hospital ( Site 3102)
  • Hospital Sibu ( Site 3101)
  • CAIMED Investigación en Salud S.A de C.V ( Site 1209)
  • Centenario Hospital Miguel Hidalgo ( Site 1204)
  • Hospital Angeles Lomas ( Site 1207)
  • Instituto Nacional de Pediatria ( Site 1202)
  • Clinica Peruano Americana S.A. ( Site 1253)
  • Asociacion Civil Selva Amazonica ( Site 1255)
  • Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)
  • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)
  • University of the Philippines-Philippine General Hospital ( Site 3152)
  • Philippine Children s Medical Center ( Site 3154)
  • Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)
  • Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)
  • Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)
  • IN VIVO ( Site 2401)
  • Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)
  • NZOZ Salmed ( Site 2433)
  • Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)
  • Centrum Medyczne PROMED ( Site 2432)
  • Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)
  • WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)
  • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)
  • Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)
  • Centrum Medyczne Pratia Warszawa ( Site 2438)
  • Uniwersyteckie Centrum Kliniczne ( Site 2437)
  • Szpital Miejski w Tychach ( Site 2442)
  • Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)
  • MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)
  • Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)
  • Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)
  • Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)
  • Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)
  • University Of The Orange Free State ( Site 2507)
  • Baragwanath Hospital ( Site 2501)
  • Empilweni Services and Research Unit ( Site 2504)
  • Steve Biko Academic Hospital ( Site 2505)
  • Enhancing Care Foundation-DICRS ( Site 2506)
  • Tygerberg Hospital ( Site 2503)
  • MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)
  • Srinagarind Hospital. Khon Kaen University ( Site 3253)
  • Chulalongkorn University-Pediatrics ( Site 3252)
  • Siriraj Hospital ( Site 3251)
  • Prince of Songkla University Faculty of Medicine ( Site 3255)
  • Maharaj Nakorn Chiang Mai Hospital ( Site 3254)
  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)
  • Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)
  • Ege University Medical Faculty ( Site 2553)
  • Erciyes University Medical Faculty-pediatric infection ( Site 2554)
  • UH Bristol Education Centre ( Site 2607)
  • St. Georges University Hospital NHS Foundation Trust ( Site 2601)
  • Royal Maternity Hospital ( Site 2602)
  • Oxford University Hospital NHS Foundation Trust ( Site 2604)
  • Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clesrovimab

Placebo

Arm Description

Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.

Participants receive a single IM administration of placebo on Day 1.

Outcomes

Primary Outcome Measures

Percentage of participants with RSV-associated MALRI
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)
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 fever
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 solicited systemic AEs
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 anaphylaxis/hypersensitivity AE of special interest (AESI)
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 rash AESI
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
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 serious adverse events (SAEs)
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

Percentage of participants with RSV-associated hospitalization
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
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.

Full Information

First Posted
February 22, 2021
Last Updated
July 14, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04767373
Brief Title
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Official Title
A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Days 1 through 150 postdose compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clesrovimab
Arm Type
Experimental
Arm Description
Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a single IM administration of placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
Clesrovimab
Other Intervention Name(s)
MK-1654
Intervention Description
Clesrovimab solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (0.9% sodium chloride [NaCL]) solution
Primary Outcome Measure Information:
Title
Percentage of participants with RSV-associated MALRI
Description
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.
Time Frame
From Day 1 (postdose) to Day 150
Title
Percentage of participants with solicited injection-site adverse events (AEs)
Description
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.
Time Frame
From Day 1 (postdose) to Day 5
Title
Percentage of participants with fever
Description
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.
Time Frame
From Day 1 (postdose) to Day 5
Title
Percentage of participants with solicited systemic AEs
Description
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.
Time Frame
From Day 1 (postdose) to Day 5
Title
Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)
Description
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.
Time Frame
From Day 1 (postdose) to Day 42
Title
Percentage of participants with rash AESI
Description
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.
Time Frame
From Day 1 (postdose) to Day 42
Title
Percentage of participants with ≥1 nonserious AE
Description
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.
Time Frame
From Day 1 (postdose) to Day 42
Title
Percentage of participants with serious adverse events (SAEs)
Description
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.
Time Frame
Up to Day 515
Secondary Outcome Measure Information:
Title
Percentage of participants with RSV-associated hospitalization
Description
RSV-associated hospitalization is defined as a hospital admission for respiratory illness AND RSV-positive RT-PCR nasopharyngeal sample.
Time Frame
From Day 1 (postdose) to Day 150
Title
Percentage of participants with RSV-associated MALRI
Description
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.
Time Frame
From Day 1 (postdose) to Day 180

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Southeastern Pediatric Associates, P.A. ( Site 0008)
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Northwest Arkansas Pediatric Clinic ( Site 0050)
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Children's Clinic of Jonesboro, PA ( Site 0058)
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Long Beach Memorial Medical Center ( Site 0014)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Madera Family Medical Group ( Site 0046)
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Orange County Research Institute ( Site 0057)
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Children's Hospital Colorado ( Site 0066)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Optumcare Colorado Springs, LLC ( Site 0022)
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Children's National Hospital ( Site 0076)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
MedStar Georgetown Pediatrics ( Site 0047)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Next Phase Research Alliance, LLC ( Site 0071)
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Acevedo Clinical Research Associates ( Site 0002)
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Tekton Research ( Site 0080)
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Meridian Clinical Research, LLC ( Site 0083)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Clinical Research Prime ( Site 0075)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saltzer Medical Group ( Site 0004)
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
ACC Pediatric Research ( Site 0067)
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
Meridian Clinical Research, LLC ( Site 0082)
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Midwest Children's Health Research Institute, LLC ( Site 0044)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center ( Site 0031)
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Rutgers University-Pediatric Clinical Research Center ( Site 0055)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Senders Pediatrics ( Site 0062)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Ohio Pediatric Research Association ( Site 0063)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
CCP- Kid's Way ( Site 0017)
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Coastal Pediatric Research ( Site 0013)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Tribe Clinical Research, LLC ( Site 0015)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Holston Medical Group ( Site 0040)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Javara - Privia Medical Group North Texas - Frisco ( Site 0086)
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
University of Texas Medical Branch at Galveston ( Site 0059)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
DM Clinical Research ( Site 0005)
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
FMC Science - Lampasas ( Site 0011)
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
DCOL Center for Clinical Research ( Site 0042)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
University Health System- San Antonio ( Site 0048)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Private Practice - Dr. Etokhana ( Site 0089)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
Road Runner Research, Ltd ( Site 0049)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0092)
City
Kaysville
State/Province
Utah
ZIP/Postal Code
84037
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0077)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cottonwood Pediatrics ( Site 0032)
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wee Care Pediatrics-Roy ( Site 0053)
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
University of Utah School of Medicine ( Site 0006)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Copperview Medical Center ( Site 0078)
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0065)
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC ( Site 0073)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
MultiCare Rockwood Cheney Clinic ( Site 0068)
City
Cheney
State/Province
Washington
ZIP/Postal Code
99004
Country
United States
Facility Name
Multicare Health System Institute for Research and Innovation ( Site 0025)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Multicare Institute For Research And Innovation ( Site 0045)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Marshall University School of Medicine and Medical Center ( Site 0064)
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Marshfield Clinic ( Site 0054)
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426BOS
Country
Argentina
Facility Name
Clinica del Nino y la Madre ( Site 1005)
City
Mar De La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYH
Country
Argentina
Facility Name
SANATORIO DEL SALVADOR-Pediatria ( Site 1008)
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
SANATORIO MATER DEI ( Site 1010)
City
Buenos Aires
ZIP/Postal Code
C1425DND
Country
Argentina
Facility Name
Clinica Privada del Sol S.A ( Site 1013)
City
Cordoba
ZIP/Postal Code
X5000IIH
Country
Argentina
Facility Name
Universitair Ziekenhuis Antwerpen ( Site 2001)
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc ( Site 2005)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cabinet Médical Demeulemeester ( Site 2002)
City
Gozée
State/Province
Wallonne, Region
ZIP/Postal Code
6534
Country
Belgium
Facility Name
AZ Delta ( Site 2004)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
University of Calgary - Alberta Children Hospital ( Site 0504)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
BC Women s Hospital and Health Centre ( Site 0506)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
Canadian Center for Vaccinology ( Site 0503)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Hamilton Medical Research Group ( Site 0509)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
CHU Sainte Justine ( Site 0502)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill University Health Centre - Vaccine Study Centre ( Site 0500)
City
Pierrefonds
State/Province
Quebec
ZIP/Postal Code
H9H 4Y6
Country
Canada
Facility Name
CHU de Quebec Universite de Laval ( Site 0501)
City
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
Facility Name
Hospital La Florida ( Site 1104)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8242238
Country
Chile
Facility Name
Hospital Roberto del Rio ( Site 1106)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380418
Country
Chile
Facility Name
Facultad Medicina Universidad de Chile ( Site 1105)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Hospital Padre Hurtado ( Site 1101)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Peking University Third Hospital ( Site 3339)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Name
The Children's Hospital of Chongqing Medical University ( Site 3333)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400065
Country
China
Facility Name
Jiangjin District Central Hospital ( Site 3319)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
402260
Country
China
Facility Name
Xiamen Maternity and Child Health Care Hospital ( Site 3351)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Guangdong Provincial People's Hospital ( Site 3341)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
Guangdong Maternity and Child Health Care Hospital ( Site 3340)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511400
Country
China
Facility Name
Liuzhou People's Hospital ( Site 3364)
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545006
Country
China
Facility Name
Hebei Petro China Central Hospital ( Site 3365)
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Facility Name
Fourth Hospital of Hebei Medical University ( Site 3366)
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050035
Country
China
Facility Name
Sanmenxia Central Hospital ( Site 3360)
City
Sanmenxia
State/Province
Henan
ZIP/Postal Code
472000
Country
China
Facility Name
Wuhan Children's Hospital ( Site 3329)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Renmin Hospital of Wuhan University ( Site 3316)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Changde First People's Hospital ( Site 3311)
City
Changde
State/Province
Hunan
ZIP/Postal Code
415000
Country
China
Facility Name
The Maternal and Child Health Hospital of Hunan Province ( Site 3334)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Hunan Provincial People's Hospital ( Site 3355)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Xiangya Hospital Central South University ( Site 3347)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Shaoyang No.1 People's Hospital ( Site 3345)
City
Shaoyang
State/Province
Hunan
ZIP/Postal Code
422000
Country
China
Facility Name
Zhongda Hospital Southeast University ( Site 3353)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangxi Provincial Children's Hospital ( Site 3313)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Third Hospital of Nanchang ( Site 3325)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital ( Site 3312)
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Facility Name
Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116012
Country
China
Facility Name
Children's Hospital of Fudan University ( Site 3361)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Name
Linfen Central Hospital ( Site 3368)
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Facility Name
Linfen People's Hospital ( Site 3363)
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041081
Country
China
Facility Name
Yuncheng Central Hospital - Eastern Hospital ( Site 3318)
City
Yuncheng Shi
State/Province
Shanxi
ZIP/Postal Code
044000
Country
China
Facility Name
Chengdu Women and Children Center Hospital ( Site 3332)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610091
Country
China
Facility Name
The First People's Hospital of Hangzhou ( Site 3342)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Ningbo Women and Children's Hospital ( Site 3314)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315012
Country
China
Facility Name
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050036
Country
Colombia
Facility Name
Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054040
Country
Colombia
Facility Name
Clinica de la Costa S.A.S. ( Site 1152)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)
City
Chía
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760001
Country
Colombia
Facility Name
Regionshospitalet Herning ( Site 2105)
City
Herning
State/Province
Midtjylland
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Regionshospitalet Nordjylland ( Site 2102)
City
Hjoerring
State/Province
Nordjylland
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Odense University Hospital ( Site 2107)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)
City
Kokkola
State/Province
Mellersta Osterbotten
ZIP/Postal Code
67100
Country
Finland
Facility Name
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Facility Name
FVR, Oulun rokotetutkimusklinikka ( Site 2158)
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
FVR, Porin rokotetutkimusklinikka ( Site 2156)
City
Pori
State/Province
Satakunta
ZIP/Postal Code
28100
Country
Finland
Facility Name
FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)
City
Seinajoki
State/Province
Sodra Osterbotten
ZIP/Postal Code
60100
Country
Finland
Facility Name
FVR, Espoon rokotetutkimusklinikka ( Site 2152)
City
Espoo
State/Province
Uusimaa
ZIP/Postal Code
02230
Country
Finland
Facility Name
FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00100
Country
Finland
Facility Name
FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00930
Country
Finland
Facility Name
FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)
City
Järvenpää
State/Province
Uusimaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
FVR, Turun rokotetutkimusklinikka ( Site 2151)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU Caen ( Site 2212)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
Groupe Hospitalier Pellegrin ( Site 2218)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier de Versailles ( Site 2206)
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78150
Country
France
Facility Name
Soroka University Medical Center Ramot Family health center ( Site 2354)
City
Be'er Sheva
ZIP/Postal Code
8471844
Country
Israel
Facility Name
Soroka Medical Center ( Site 2351)
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center ( Site 2352)
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Soroka University Medical Center Rahat Family health center ( Site 2355)
City
Rahat
ZIP/Postal Code
8535700
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 2353)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Policlinico Universitario Gemelli ( Site 2301)
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.Universitaria Meyer ( Site 2306)
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
Universita degli studi di Padova Patologia e TIN ( Site 2305)
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O. Policlinico Consorziale di Bari ( Site 2309)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Maebashi Red Cross Hospital ( Site 3057)
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0811
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital ( Site 3060)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
JOHAS Yokohama Rosai Hospital ( Site 3058)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center ( Site 3063)
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Ageo Central General Hospital ( Site 3051)
City
Ageo
State/Province
Saitama
ZIP/Postal Code
362-8588
Country
Japan
Facility Name
Tottori University Hospital ( Site 3053)
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Fukui Aiiku Hospital ( Site 3056)
City
Fukui
ZIP/Postal Code
910-0833
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital ( Site 3064)
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Saitama City Hospital ( Site 3055)
City
Saitama
ZIP/Postal Code
336-8522
Country
Japan
Facility Name
Shizuoka City Shimizu Hospital ( Site 3061)
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
St.Luke's International Hospital ( Site 3062)
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Showa University Hospital ( Site 3059)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)
City
Bupyeong-gu
State/Province
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Jeonbuk National University Hospital ( Site 3210)
City
Jeonju-si
State/Province
Jeonrabugdo
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital ( Site 3212)
City
Ansan-si
State/Province
Kyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital ( Site 3207)
City
Anyang
State/Province
Kyonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital-Pediatrics ( Site 3204)
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Hospital ( Site 3206)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungang University Hospital ( Site 3211)
City
Dongjak-gu
State/Province
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 3203)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 3201)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 3202)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Raja Perempuan Zainab II ( Site 3106)
City
Kota Bahru
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Hospital Seri Manjung ( Site 3103)
City
Seri Manjung
State/Province
Perak
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Hospital Taiping ( Site 3108)
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Hospital Pulau Pinang ( Site 3104)
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Seberang Jaya ( Site 3107)
City
Seberang Jaya
State/Province
Pulau Pinang
ZIP/Postal Code
13700
Country
Malaysia
Facility Name
Sabah Womens & Childrens Hospital ( Site 3102)
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Hospital Sibu ( Site 3101)
City
Sibu
State/Province
Sarawak
ZIP/Postal Code
96000
Country
Malaysia
Facility Name
CAIMED Investigación en Salud S.A de C.V ( Site 1209)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Centenario Hospital Miguel Hidalgo ( Site 1204)
City
Aguascalientes
ZIP/Postal Code
20259
Country
Mexico
Facility Name
Hospital Angeles Lomas ( Site 1207)
City
Huixquilucan
ZIP/Postal Code
52763
Country
Mexico
Facility Name
Instituto Nacional de Pediatria ( Site 1202)
City
Mexico City
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Clinica Peruano Americana S.A. ( Site 1253)
City
Trujillo
State/Province
La Libertad
ZIP/Postal Code
13011
Country
Peru
Facility Name
Asociacion Civil Selva Amazonica ( Site 1255)
City
Iquitos
State/Province
Loreto
ZIP/Postal Code
16001
Country
Peru
Facility Name
Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)
City
Lima
ZIP/Postal Code
LIMA 36
Country
Peru
Facility Name
University of the Philippines-Philippine General Hospital ( Site 3152)
City
Manila
State/Province
National Capital Region
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Philippine Children s Medical Center ( Site 3154)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1118
Country
Philippines
Facility Name
Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)
City
Trzebnica
State/Province
Dolnoslaskie
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-368
Country
Poland
Facility Name
IN VIVO ( Site 2401)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-347
Country
Poland
Facility Name
NZOZ Salmed ( Site 2433)
City
Leczna
State/Province
Lubelskie
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Centrum Medyczne PROMED ( Site 2432)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-411
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa ( Site 2438)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne ( Site 2437)
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Szpital Miejski w Tychach ( Site 2442)
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-129
Country
Poland
Facility Name
MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)
City
Mazowieckie
ZIP/Postal Code
02-972
Country
Poland
Facility Name
Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)
City
Brasov
ZIP/Postal Code
500063
Country
Romania
Facility Name
Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)
City
Bucuresti
ZIP/Postal Code
011171
Country
Romania
Facility Name
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)
City
Iasi
ZIP/Postal Code
700038
Country
Romania
Facility Name
University Of The Orange Free State ( Site 2507)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Baragwanath Hospital ( Site 2501)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Empilweni Services and Research Unit ( Site 2504)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2093
Country
South Africa
Facility Name
Steve Biko Academic Hospital ( Site 2505)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Enhancing Care Foundation-DICRS ( Site 2506)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Tygerberg Hospital ( Site 2503)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Srinagarind Hospital. Khon Kaen University ( Site 3253)
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Chulalongkorn University-Pediatrics ( Site 3252)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital ( Site 3251)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Prince of Songkla University Faculty of Medicine ( Site 3255)
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 3254)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Ege University Medical Faculty ( Site 2553)
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Erciyes University Medical Faculty-pediatric infection ( Site 2554)
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
UH Bristol Education Centre ( Site 2607)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
St. Georges University Hospital NHS Foundation Trust ( Site 2601)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Maternity Hospital ( Site 2602)
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BB
Country
United Kingdom
Facility Name
Oxford University Hospital NHS Foundation Trust ( Site 2604)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34774184
Citation
Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1654-004&kw=1654-004
Description
Plain Language Summary

Learn more about this trial

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

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