Back to resultsClesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Primary Purpose
RSV Infection
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clesrovimab
Palivizumab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for RSV Infection
Eligibility Criteria
Inclusion Criteria:
- Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- Is available to complete the follow-up period.
Exclusion Criteria:
- Requires mechanical ventilation at time of enrollment.
- Has a life expectancy <6 months.
- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- Has severe immunodeficiency or is severely immunocompromised.
- Has known hypersensitivity to any component of clesrovimab or palivizumab.
Sites / Locations
- Miller Children's & Women's Hospital Long Beach ( Site 0001)
- Children's Hospital of Orange County ( Site 0047)Recruiting
- Children's Hospital Colorado ( Site 0011)
- Children's National Medical Center ( Site 0020)Recruiting
- Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep MRecruiting
- Nemours Children's Health, Lake Nona Medical City ( Site 0032)Recruiting
- University of South Florida-Department of Pediatrics ( Site 0045)Recruiting
- Morehouse School Of Medicine ( Site 0049)Recruiting
- Clinical Research Prime ( Site 0046)
- University of Kentucky HealthCare - Turfland ( Site 0044)
- Our Lady of the Lake Children's Hospital ( Site 0031)
- Tulane University School of Medicine ( Site 0010)
- M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit
- Rutgers University-Pediatric Clinical Research Center ( Site 0007)Recruiting
- NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)Recruiting
- University of Rochester Medical Center ( Site 0017)Recruiting
- The University of North Carolina at Chapel Hill ( Site 0035)Recruiting
- Duke University ( Site 0021)Recruiting
- Dayton Children's Hospital ( Site 0053)
- Tribe Clinical Research, LLC ( Site 0002)Recruiting
- Driscoll Children's Hospital ( Site 0025)Recruiting
- DHR Health Institute for Research and Development ( Site 0029)Recruiting
- The Children's Hospital of San Antonio ( Site 0038)Recruiting
- University Hospital-Pediatrics ( Site 0019)Recruiting
- Road Runner Research, Ltd ( Site 0052)Recruiting
- Intermountain - Primary Children's Hospital ( Site 0026)
- Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
- Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
- MultiCare Health System-Baker Center ( Site 0036)Recruiting
- Mater Misericordiae Limited-Neonatalogy ( Site 0102)Recruiting
- Telethon Kids Institute-Vaccine Trials Group ( Site 0101)Recruiting
- Alberta Children's Hospital-Department of Pediatrics ( Site 0180)Recruiting
- Canadian Center for Vaccinology ( Site 0179)Recruiting
- CHU Sainte-Justine ( Site 0178)Recruiting
- Clínica Alemana de Santiago-Neonatology department ( Site 0207)Recruiting
- Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)Recruiting
- Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)Recruiting
- Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
- Clínica Universitaria Bolivariana ( Site 0227)Recruiting
- Ciensalud Ips S A S ( Site 0235)Recruiting
- Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)Recruiting
- Clínica Imbanaco S.A.S ( Site 0229)Recruiting
- Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)Recruiting
- Institute for the Care of Mother and Child ( Site 0251)Recruiting
- FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)Recruiting
- FVR, Tampereen rokotetutkimusklinikka ( Site 0301)Recruiting
- FVR, Oulun rokotetutkimusklinikka ( Site 0303)Recruiting
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)Recruiting
- MeVac - Meilahti Vaccine Research Center ( Site 0306)Recruiting
- FVR, Turun rokotetutkimusklinikka ( Site 0302)Recruiting
- Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)Recruiting
- Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
- Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
- Universitaetsklinikum Freiburg ( Site 0365)Recruiting
- Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)Recruiting
- Dr. von Haunersches Kinderspital ( Site 0358)Recruiting
- München Klinik Harlaching ( Site 0351)Recruiting
- Medizinische Hochschule Hannover ( Site 0364)Recruiting
- Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Leipzig-Neonatology ( Site 0354)Recruiting
- Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
- Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian UniversiRecruiting
- Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)Recruiting
- ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)Recruiting
- Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)Recruiting
- Prince of Wales Hospital ( Site 0926)Recruiting
- Tuen Mun Hospital ( Site 0927)Recruiting
- Bajai Szent Rókus Kórház ( Site 0386)Recruiting
- Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)Recruiting
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( SiRecruiting
- Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)Recruiting
- Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)Recruiting
- Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)Recruiting
- Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 0378)Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)Recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)Recruiting
- Ospedale Pediatrico Bambino Gesù IRCCS ( Site 0427)Recruiting
- Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)Recruiting
- Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)Recruiting
- Fukuoka Children's Hospital ( Site 0452)
- Aso Iizuka Hospital ( Site 0457)
- Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
- Maebashi Red Cross Hospital ( Site 0451)
- Ibaraki Children's Hospital ( Site 0458)
- Nihon University Itabashi Hospital ( Site 0453)
- Shizuoka Saiseikai General Hospital ( Site 0456)
- National Center for Child Health and Development ( Site 0455)
- Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)Recruiting
- University Malaya Medical Centre-Department of Paediatrics ( Site 0480)Recruiting
- Hospital Pulau Pinang ( Site 0482)Recruiting
- Sabah Women and Children Hospital ( Site 0478)Recruiting
- Hospital Sibu ( Site 0476)Recruiting
- Hospital Tunku Azizah-Paediatric ( Site 0481)Recruiting
- Instituto Nacional de Pediatria ( Site 0506)Recruiting
- Morales Vargas Centro de Investigacion ( Site 0509)Recruiting
- Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)Recruiting
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)Recruiting
- Oaxaca Site Management Organization ( Site 0504)Recruiting
- ONCOLOGICO POTOSINO, S.C. ( Site 0505)
- Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)Recruiting
- Middlemore Clinical Trials ( Site 0526)Recruiting
- Oslo Universitetssykehus Ullevål ( Site 0551)Recruiting
- Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)Recruiting
- HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)Recruiting
- UPR Medical Sciences Campus-Pediatrics ( Site 0626)Recruiting
- KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)Recruiting
- Reimed ( Site 0706)
- Chris Hani Baragwanath Academic Hospital ( Site 0701)
- King Edward VIII Hospital ( Site 0704)
- Panorama Medical Centre ( Site 0702)Recruiting
- Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)Recruiting
- MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)Recruiting
- 2 Military Hospital ( Site 0708)Recruiting
- Hospital Universitario Central de Asturias ( Site 0740)Recruiting
- Hospital Germans Trias i Pujol ( Site 0738)Recruiting
- Hospital Sant Joan de Déu ( Site 0730)Recruiting
- Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
- CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
- Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)Recruiting
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)Recruiting
- Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07Recruiting
- Hospital Universitario La Paz ( Site 0726)Recruiting
- Grupo Pediatrico Uncibay ( Site 0734)Recruiting
- Taichung Veterans General Hospital ( Site 0754)Recruiting
- National Taiwan University Hospital ( Site 0751)Recruiting
- Mackay Memorial Hospital-Pediatrics ( Site 0753)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 0752)Recruiting
- Chulalongkorn University-Pediatrics ( Site 0777)
- Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
- Songklanagarind hospital-Department of Pediatrics ( Site 0776)
- cukurova universty ( Site 0805)Recruiting
- Ankara University Hospital Cebeci ( Site 0801)Recruiting
- Gazi Universitesi ( Site 0806)Recruiting
- Ankara Bilkent Şehir Hastanesi. ( Site 0807)Recruiting
- Erciyes University Medical Faculty-pediatric infection ( Site 0804)Recruiting
- Whipps Cross University Hospital ( Site 0846)Recruiting
- St. George's Hospital ( Site 0845)Recruiting
- Queen Elizabeth University Hospital ( Site 0842)Recruiting
- Evelina London Children's Hospital ( Site 0829)Recruiting
- Southampton General Hospital ( Site 0826)Recruiting
- Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)Recruiting
- The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)Recruiting
- Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clesrovimab
Palivizumab
Arm Description
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Participants will receive IM injections.
Outcomes
Primary Outcome Measures
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
Percentage of participants with solicited injection-site AEs in RSV Season 1
Participants with solicited daily body temperature with fever in RSV Season 1
Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Participants with solicited systemic AEs in RSV Season 1
Percentage of participants with solicited systemic AEs in RSV Season 1
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Participants with rash AESI in RSV Season 1
Percentage of participants with rash AESI in RSV Season 1
Participants with non-serious AEs in RSV Season 1
Percentage of participants with non-serious AEs in RSV Season 1
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Secondary Outcome Measures
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Participants with RSV-associated hospitalization in RSV Season 1
Percentage of participants with RSV-associated hospitalization in RSV Season 1
Participants with solicited injection-site AEs in RSV Season 2
Percentage of participants with solicited injection-site AEs in RSV Season 2
Participants with solicited daily body temperature with fever in RSV Season 2
Percentage of participants with solicited daily body temperature with fever in RSV Season 2
Participants with solicited systemic AEs in RSV Season 2
Percentage of participants with solicited systemic AEs in RSV Season 2
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Participants with rash AESI in RSV Season 2
Percentage of participants with rash AESI in RSV Season 2
Participants with non-serious AEs in RSV Season 2
Percentage of participants with non-serious AEs in RSV Season 2
Participants with SAEs in RSV Season 2
Percentage of participants with SAEs in RSV Season 2
Concentration of clesrovimab in RSV Season 1
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1
Concentration of clesrovimab in RSV Season 2
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
Full Information
NCT ID
NCT04938830
First Posted
June 22, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04938830
Brief Title
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Official Title
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
August 21, 2025 (Anticipated)
Study Completion Date
April 27, 2026 (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
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clesrovimab
Arm Type
Experimental
Arm Description
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Arm Title
Palivizumab
Arm Type
Active Comparator
Arm Description
Participants will receive IM injections.
Intervention Type
Biological
Intervention Name(s)
Clesrovimab
Other Intervention Name(s)
MK-1654
Intervention Description
IM injection
Intervention Type
Biological
Intervention Name(s)
Palivizumab
Intervention Description
IM injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
IM injection
Primary Outcome Measure Information:
Title
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
Description
Percentage of participants with solicited injection-site AEs in RSV Season 1
Time Frame
Up to 5 days
Title
Participants with solicited daily body temperature with fever in RSV Season 1
Description
Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Time Frame
Up to 5 days
Title
Participants with solicited systemic AEs in RSV Season 1
Description
Percentage of participants with solicited systemic AEs in RSV Season 1
Time Frame
Up to 5 days
Title
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Description
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Time Frame
Up to 42 days
Title
Participants with rash AESI in RSV Season 1
Description
Percentage of participants with rash AESI in RSV Season 1
Time Frame
Up to 42 days
Title
Participants with non-serious AEs in RSV Season 1
Description
Percentage of participants with non-serious AEs in RSV Season 1
Time Frame
Up to 42 days
Title
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Description
Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Time Frame
Up to 365 days
Secondary Outcome Measure Information:
Title
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Description
Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Time Frame
Up to 150 days
Title
Participants with RSV-associated hospitalization in RSV Season 1
Description
Percentage of participants with RSV-associated hospitalization in RSV Season 1
Time Frame
Up to 150 days
Title
Participants with solicited injection-site AEs in RSV Season 2
Description
Percentage of participants with solicited injection-site AEs in RSV Season 2
Time Frame
From approximately 393 days up to 400 days
Title
Participants with solicited daily body temperature with fever in RSV Season 2
Description
Percentage of participants with solicited daily body temperature with fever in RSV Season 2
Time Frame
From approximately 393 days up to 400 days
Title
Participants with solicited systemic AEs in RSV Season 2
Description
Percentage of participants with solicited systemic AEs in RSV Season 2
Time Frame
From approximately 393 days up to 400 days
Title
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Description
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Time Frame
From approximately 393 days up to 440 days
Title
Participants with rash AESI in RSV Season 2
Description
Percentage of participants with rash AESI in RSV Season 2
Time Frame
From approximately 393 days up to 440 days
Title
Participants with non-serious AEs in RSV Season 2
Description
Percentage of participants with non-serious AEs in RSV Season 2
Time Frame
From approximately 393 days up to 440 days
Title
Participants with SAEs in RSV Season 2
Description
Percentage of participants with SAEs in RSV Season 2
Time Frame
From approximately 393 days up to 575 days
Title
Concentration of clesrovimab in RSV Season 1
Description
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1
Time Frame
Up to 240 days
Title
Concentration of clesrovimab in RSV Season 2
Description
Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
Time Frame
From approximately 393 days up to 550 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
Is available to complete the follow-up period.
Exclusion Criteria:
Requires mechanical ventilation at time of enrollment.
Has a life expectancy <6 months.
Has known hepatic or renal dysfunction, or chronic seizure disorder.
Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
Has severe immunodeficiency or is severely immunocompromised.
Has known hypersensitivity to any component of clesrovimab or palivizumab.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
Miller Children's & Women's Hospital Long Beach ( Site 0001)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Orange County ( Site 0047)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
503-332-2004
Facility Name
Children's Hospital Colorado ( Site 0011)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Children's National Medical Center ( Site 0020)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-276-4293
Facility Name
Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
321-841-6350
Facility Name
Nemours Children's Health, Lake Nona Medical City ( Site 0032)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-567-7424
Facility Name
University of South Florida-Department of Pediatrics ( Site 0045)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913-832-4946
Facility Name
Morehouse School Of Medicine ( Site 0049)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-756-1326
Facility Name
Clinical Research Prime ( Site 0046)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Completed
Facility Name
University of Kentucky HealthCare - Turfland ( Site 0044)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Completed
Facility Name
Our Lady of the Lake Children's Hospital ( Site 0031)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Completed
Facility Name
Tulane University School of Medicine ( Site 0010)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Completed
Facility Name
M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Completed
Facility Name
Rutgers University-Pediatric Clinical Research Center ( Site 0007)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
732-235-5976
Facility Name
NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-592-9188
Facility Name
University of Rochester Medical Center ( Site 0017)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
585-275-2981
Facility Name
The University of North Carolina at Chapel Hill ( Site 0035)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-708-2749
Facility Name
Duke University ( Site 0021)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
919-260-7626
Facility Name
Dayton Children's Hospital ( Site 0053)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45449
Country
United States
Individual Site Status
Completed
Facility Name
Tribe Clinical Research, LLC ( Site 0002)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
864-334-0141
Facility Name
Driscoll Children's Hospital ( Site 0025)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
361-739-8496
Facility Name
DHR Health Institute for Research and Development ( Site 0029)
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
956-802-8855
Facility Name
The Children's Hospital of San Antonio ( Site 0038)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-704-2472
Facility Name
University Hospital-Pediatrics ( Site 0019)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-254-6317
Facility Name
Road Runner Research, Ltd ( Site 0052)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-949-0505
Facility Name
Intermountain - Primary Children's Hospital ( Site 0026)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Completed
Facility Name
Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Completed
Facility Name
Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MultiCare Health System-Baker Center ( Site 0036)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-657-9037
Facility Name
Mater Misericordiae Limited-Neonatalogy ( Site 0102)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07 3163 8868
Facility Name
Telethon Kids Institute-Vaccine Trials Group ( Site 0101)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0863191852
Facility Name
Alberta Children's Hospital-Department of Pediatrics ( Site 0180)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4039552952
Facility Name
Canadian Center for Vaccinology ( Site 0179)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
9024708141
Facility Name
CHU Sainte-Justine ( Site 0178)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5143454931
Facility Name
Clínica Alemana de Santiago-Neonatology department ( Site 0207)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8320325
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56996197211
Facility Name
Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380418
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56996197211
Facility Name
Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8880465
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994346039
Facility Name
Fundación Hospitalaria San Vicente de Paúl ( Site 0233)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Individual Site Status
Completed
Facility Name
Clínica Universitaria Bolivariana ( Site 0227)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
50036
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+57 3108239876
Facility Name
Ciensalud Ips S A S ( Site 0235)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
08001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573004691661
Facility Name
Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
11001000
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573008162821
Facility Name
Clínica Imbanaco S.A.S ( Site 0229)
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573146287331
Facility Name
Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420597371401
Facility Name
Institute for the Care of Mother and Child ( Site 0251)
City
Prague
State/Province
Praha 4
ZIP/Postal Code
14700
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+420296511806
Facility Name
FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)
City
Kokkola
State/Province
Mellersta Osterbotten
ZIP/Postal Code
67100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358401904121
Facility Name
FVR, Tampereen rokotetutkimusklinikka ( Site 0301)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358 50 443 7254
Facility Name
FVR, Oulun rokotetutkimusklinikka ( Site 0303)
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358 50 531 0004
Facility Name
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)
City
Seinajoki
State/Province
Sodra Osterbotten
ZIP/Postal Code
60100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358401904119
Facility Name
MeVac - Meilahti Vaccine Research Center ( Site 0306)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
358504270446
Facility Name
FVR, Turun rokotetutkimusklinikka ( Site 0302)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358 50 443 7254
Facility Name
Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33556795679
Facility Name
Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78157
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Freiburg ( Site 0365)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004976127043230
Facility Name
Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00496221564606
Facility Name
Dr. von Haunersches Kinderspital ( Site 0358)
City
Munich
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
49-89-44005-7970
Facility Name
München Klinik Harlaching ( Site 0351)
City
Munich
State/Province
Bayern
ZIP/Postal Code
81545
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00498962102720
Facility Name
Medizinische Hochschule Hannover ( Site 0364)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
004917615327436
Facility Name
Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00493514583640
Facility Name
Universitätsklinikum Leipzig-Neonatology ( Site 0354)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00493419726037
Facility Name
Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Completed
Facility Name
Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306974420425
Facility Name
Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302107793000
Facility Name
ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302105832233
Facility Name
Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)
City
Thessaloniki
State/Province
Kentriki Makedonia
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302313312444
Facility Name
Prince of Wales Hospital ( Site 0926)
City
Shatin
ZIP/Postal Code
NT
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
35052982
Facility Name
Tuen Mun Hospital ( Site 0927)
City
Tuen Mun
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
64680199
Facility Name
Bajai Szent Rókus Kórház ( Site 0386)
City
Baja
State/Province
Bacs-Kiskun
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36202702610
Facility Name
Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36302497387
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36209532890
Facility Name
Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3642599700
Facility Name
Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3614614750
Facility Name
Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36 1 459 1500
Facility Name
Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3612151220
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 0378)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36304568755
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 06 30154475
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390255032907
Facility Name
Ospedale Pediatrico Bambino Gesù IRCCS ( Site 0427)
City
Rome
State/Province
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390668593077
Facility Name
Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390498213578
Facility Name
Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390521903524
Facility Name
Fukuoka Children's Hospital ( Site 0452)
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Aso Iizuka Hospital ( Site 0457)
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Maebashi Red Cross Hospital ( Site 0451)
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0811
Country
Japan
Individual Site Status
Completed
Facility Name
Ibaraki Children's Hospital ( Site 0458)
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4145
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nihon University Itabashi Hospital ( Site 0453)
City
Itabashiku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Shizuoka Saiseikai General Hospital ( Site 0456)
City
Shizuoka
ZIP/Postal Code
422-8527
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Center for Child Health and Development ( Site 0455)
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Completed
Facility Name
Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6097452636
Facility Name
University Malaya Medical Centre-Department of Paediatrics ( Site 0480)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
60379492260
Facility Name
Hospital Pulau Pinang ( Site 0482)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60 4-222 5333
Facility Name
Sabah Women and Children Hospital ( Site 0478)
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6088522600
Facility Name
Hospital Sibu ( Site 0476)
City
Sibu
State/Province
Sarawak
ZIP/Postal Code
96000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6084314569
Facility Name
Hospital Tunku Azizah-Paediatric ( Site 0481)
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+603-26003000
Facility Name
Instituto Nacional de Pediatria ( Site 0506)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+525556069738
Facility Name
Morales Vargas Centro de Investigacion ( Site 0509)
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+524777160714
Facility Name
Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 33 1131 4872
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 6181527904
Facility Name
Oaxaca Site Management Organization ( Site 0504)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+529515147056
Facility Name
ONCOLOGICO POTOSINO, S.C. ( Site 0505)
City
San Luis Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Completed
Facility Name
Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6449185117
Facility Name
Middlemore Clinical Trials ( Site 0526)
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+64925038288952
Facility Name
Oslo Universitetssykehus Ullevål ( Site 0551)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+47 22118765
Facility Name
Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)
City
Jesús María
State/Province
Lima
ZIP/Postal Code
15072
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51992815948
Facility Name
HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51999643599
Facility Name
UPR Medical Sciences Campus-Pediatrics ( Site 0626)
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
78775825251576
Facility Name
KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)
City
Singapore
State/Province
South West
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+65 6225 5554
Facility Name
Reimed ( Site 0706)
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1459
Country
South Africa
Individual Site Status
Completed
Facility Name
Chris Hani Baragwanath Academic Hospital ( Site 0701)
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
King Edward VIII Hospital ( Site 0704)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Panorama Medical Centre ( Site 0702)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27834952368
Facility Name
Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
2781466 9392
Facility Name
MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27798932840
Facility Name
2 Military Hospital ( Site 0708)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7824
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
021 799 6223
Facility Name
Hospital Universitario Central de Asturias ( Site 0740)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3498510800037508
Facility Name
Hospital Germans Trias i Pujol ( Site 0738)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
934651200
Facility Name
Hospital Sant Joan de Déu ( Site 0730)
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34932804000x70218
Facility Name
Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Completed
Facility Name
CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 659 33 61 84
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914521920
Facility Name
Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07
City
Madrid
ZIP/Postal Code
28026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913908569
Facility Name
Hospital Universitario La Paz ( Site 0726)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34917277416
Facility Name
Grupo Pediatrico Uncibay ( Site 0734)
City
Malaga
ZIP/Postal Code
29015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34952220176
Facility Name
Taichung Veterans General Hospital ( Site 0754)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886933189415
Facility Name
National Taiwan University Hospital ( Site 0751)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886223123456 ext 71525
Facility Name
Mackay Memorial Hospital-Pediatrics ( Site 0753)
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886975835388
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 0752)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88633281200 ext 8896
Facility Name
Chulalongkorn University-Pediatrics ( Site 0777)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
Songklanagarind hospital-Department of Pediatrics ( Site 0776)
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
cukurova universty ( Site 0805)
City
Sarçam
State/Province
Adana
ZIP/Postal Code
01030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905326534166
Facility Name
Ankara University Hospital Cebeci ( Site 0801)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905058392717
Facility Name
Gazi Universitesi ( Site 0806)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905422946435
Facility Name
Ankara Bilkent Şehir Hastanesi. ( Site 0807)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905055668716
Facility Name
Erciyes University Medical Faculty-pediatric infection ( Site 0804)
City
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905057011878
Facility Name
Whipps Cross University Hospital ( Site 0846)
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02085395522
Facility Name
St. George's Hospital ( Site 0845)
City
London
State/Province
England
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02087252788
Facility Name
Queen Elizabeth University Hospital ( Site 0842)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01414514887
Facility Name
Evelina London Children's Hospital ( Site 0829)
City
London
State/Province
Great Britain
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020 7188 7188
Facility Name
Southampton General Hospital ( Site 0826)
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07931810098
Facility Name
Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
447801968718
Facility Name
The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
447831638192
Facility Name
Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07515409417
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
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=1654-007&kw=1654-007
Description
Plain Language Summary
Learn more about this trial
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
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