Clinical trial NCT04767373: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Respiratory Syncytial Virus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 3632
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 respiratory syncytial virus (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

Primary outcomes:
measure: RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
timeFrame: From Day 1 (postdose) to Day 150
measure: RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
timeFrame: From Day 1 (postdose) to Day 5
measure: RSV Season 1: Percentage of Participants With Fever
timeFrame: From Day 1 (postdose) to Day 5
measure: RSV Season 1: Percentage of Participants With Solicited Systemic AEs
timeFrame: From Day 1 (postdose) to Day 5
measure: RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
timeFrame: From Day 1 (postdose) to Day 42
measure: RSV Season 1: Percentage of Participants With Rash AESI
timeFrame: From Day 1 (postdose) to Day 42
measure: RSV Season 1: Percentage of Participants With ≥1 Nonserious AE
timeFrame: From Day 1 (postdose) to Day 42
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
Secondary outcomes:
measure: RSV Season 1: Number of Participants With RSV-Associated Hospitalization
timeFrame: From Day 1 (postdose) to Day 150
measure: RSV Season 1: Number of Participants With RSV-Associated MALRI
timeFrame: From Day 1 (postdose) to Day 180
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Southeastern Pediatric Associates, P.A. ( Site 0008)
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic ( Site 0050)
state: Arkansas
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0058)
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center ( Site 0014)
state: California
city: Madera
country: United States
facility: Madera Family Medical Group ( Site 0046)
state: California
city: Ontario
country: United States
facility: Orange County Research Institute ( Site 0057)
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado ( Site 0066)
state: Colorado
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC ( Site 0022)
state: Colorado
city: Washington
country: United States
facility: Children's National Hospital ( Site 0076)
state: District of Columbia
city: Washington
country: United States
facility: MedStar Georgetown Pediatrics ( Site 0047)
state: District of Columbia
city: Homestead
country: United States
facility: Next Phase Research Alliance, LLC ( Site 0071)
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates ( Site 0002)
state: Florida
city: Chamblee
country: United States
facility: Tekton Research ( Site 0080)
state: Georgia
city: Macon
country: United States
facility: Meridian Clinical Research, LLC ( Site 0083)
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime ( Site 0075)
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group ( Site 0004)
state: Idaho
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)
state: Kansas
city: Haughton
country: United States
facility: ACC Pediatric Research ( Site 0067)
state: Louisiana
city: Hastings
country: United States
facility: Meridian Clinical Research, LLC ( Site 0082)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC ( Site 0044)
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center ( Site 0031)
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers University-Pediatric Clinical Research Center ( Site 0055)
state: New Jersey
city: Winston-Salem
country: United States
facility: Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)
state: North Carolina
city: Cleveland
country: United States
facility: Senders Pediatrics ( Site 0062)
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association ( Site 0063)
state: Ohio
city: Hermitage
country: United States
facility: CCP- Kid's Way ( Site 0017)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research ( Site 0013)
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC ( Site 0015)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0040)
state: Tennessee
city: Frisco
country: United States
facility: Javara - Privia Medical Group North Texas - Frisco ( Site 0086)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston ( Site 0059)
state: Texas
city: Houston
country: United States
facility: DM Clinical Research ( Site 0005)
state: Texas
city: Lampasas
country: United States
facility: FMC Science - Lampasas ( Site 0011)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 0042)
state: Texas
city: San Antonio
country: United States
facility: University Health System- San Antonio ( Site 0048)
state: Texas
city: San Antonio
country: United States
facility: Private Practice - Dr. Etokhana ( Site 0089)
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd ( Site 0049)
state: Texas
city: Kaysville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0092)
state: Utah
city: Layton
country: United States
facility: Wee Care Pediatrics ( Site 0077)
state: Utah
city: Murray
country: United States
facility: Cottonwood Pediatrics ( Site 0032)
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics-Roy ( Site 0053)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine ( Site 0006)
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center ( Site 0078)
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics ( Site 0065)
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC ( Site 0073)
state: Virginia
city: Cheney
country: United States
facility: MultiCare Rockwood Cheney Clinic ( Site 0068)
state: Washington
city: Spokane
country: United States
facility: Multicare Health System Institute for Research and Innovation ( Site 0025)
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute For Research And Innovation ( Site 0045)
state: Washington
city: Huntington
country: United States
facility: Marshall University School of Medicine and Medical Center ( Site 0064)
state: West Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic ( Site 0054)
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)
state: Buenos Aires
city: Mar De La Plata
country: Argentina
facility: Clinica del Nino y la Madre ( Site 1005)
state: Buenos Aires
city: Córdoba
country: Argentina
facility: SANATORIO DEL SALVADOR-Pediatria ( Site 1008)
state: Cordoba
city: Buenos Aires
country: Argentina
facility: SANATORIO MATER DEI ( Site 1010)
city: Cordoba
country: Argentina
facility: Clinica Privada del Sol S.A ( Site 1013)
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen ( Site 2001)
state: Antwerpen
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)
state: Bruxelles-Capitale, Region De
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc ( Site 2005)
state: Bruxelles-Capitale, Region De
city: Gozée
country: Belgium
facility: Cabinet Médical Demeulemeester ( Site 2002)
state: Wallonne, Region
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 2004)
state: West-Vlaanderen
city: Calgary
country: Canada
facility: University of Calgary - Alberta Children Hospital ( Site 0504)
state: Alberta
city: Vancouver
country: Canada
facility: BC Women s Hospital and Health Centre ( Site 0506)
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology ( Site 0503)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0509)
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte Justine ( Site 0502)
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre ( Site 0500)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite de Laval ( Site 0501)
city: Santiago
country: Chile
facility: Hospital La Florida ( Site 1104)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Roberto del Rio ( Site 1106)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Facultad Medicina Universidad de Chile ( Site 1105)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Padre Hurtado ( Site 1101)
state: Region M. De Santiago
city: Beijing
country: China
facility: Peking University Third Hospital ( Site 3339)
state: Beijing
city: Chongqing
country: China
facility: The Children's Hospital of Chongqing Medical University ( Site 3333)
state: Chongqing
city: Chongqing
country: China
facility: Jiangjin District Central Hospital ( Site 3319)
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Maternity and Child Health Care Hospital ( Site 3351)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital ( Site 3341)
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Maternity and Child Health Care Hospital ( Site 3340)
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital ( Site 3364)
state: Guangxi
city: Langfang
country: China
facility: Hebei Petro China Central Hospital ( Site 3365)
state: Hebei
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University ( Site 3366)
state: Hebei
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital ( Site 3360)
state: Henan
city: Wuhan
country: China
facility: Wuhan Children's Hospital ( Site 3329)
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University ( Site 3316)
state: Hubei
city: Changde
country: China
facility: Changde First People's Hospital ( Site 3311)
state: Hunan
city: Changsha
country: China
facility: The Maternal and Child Health Hospital of Hunan Province ( Site 3334)
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial People's Hospital ( Site 3355)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University ( Site 3347)
state: Hunan
city: Shaoyang
country: China
facility: Hunan Shaoyang No.1 People's Hospital ( Site 3345)
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University ( Site 3353)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital ( Site 3313)
state: Jiangxi
city: Nanchang
country: China
facility: The Third Hospital of Nanchang ( Site 3325)
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital ( Site 3312)
state: Jiangxi
city: Dalian
country: China
facility: Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33
state: Liaoning
city: Shanghai
country: China
facility: Children's Hospital of Fudan University ( Site 3361)
state: Shanghai
city: Linfen
country: China
facility: Linfen Central Hospital ( Site 3368)
state: Shanxi
city: Linfen
country: China
facility: Linfen People's Hospital ( Site 3363)
state: Shanxi
city: Yuncheng Shi
country: China
facility: Yuncheng Central Hospital - Eastern Hospital ( Site 3318)
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women and Children Center Hospital ( Site 3332)
state: Sichuan
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou ( Site 3342)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital ( Site 3314)
state: Zhejiang
city: Medellin
country: Colombia
facility: Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)
state: Antioquia
city: Rionegro
country: Colombia
facility: Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 1152)
state: Atlantico
city: Chía
country: Colombia
facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)
state: Cundinamarca
city: Cali
country: Colombia
facility: Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)
state: Valle Del Cauca
city: Herning
country: Denmark
facility: Regionshospitalet Herning ( Site 2105)
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)
state: Nordjylland
city: Hjoerring
country: Denmark
facility: Regionshospitalet Nordjylland ( Site 2102)
state: Nordjylland
city: Odense
country: Denmark
facility: Odense University Hospital ( Site 2107)
state: Syddanmark
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)
state: Mellersta Osterbotten
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka ( Site 2158)
state: Pohjois-Pohjanmaa
city: Pori
country: Finland
facility: FVR, Porin rokotetutkimusklinikka ( Site 2156)
state: Satakunta
city: Seinajoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)
state: Sodra Osterbotten
city: Espoo
country: Finland
facility: FVR, Espoon rokotetutkimusklinikka ( Site 2152)
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)
state: Uusimaa
city: Järvenpää
country: Finland
facility: FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka ( Site 2151)
state: Varsinais-Suomi
city: Caen
country: France
facility: CHU Caen ( Site 2212)
state: Calvados
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin ( Site 2218)
state: Gironde
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles ( Site 2206)
state: Yvelines
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center Ramot Family health center ( Site 2354)
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center ( Site 2351)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 2352)
city: Rahat
country: Israel
facility: Soroka University Medical Center Rahat Family health center ( Site 2355)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 2353)
city: Rome
country: Italy
facility: Policlinico Universitario Gemelli ( Site 2301)
state: Roma
city: Firenze
country: Italy
facility: A.O.Universitaria Meyer ( Site 2306)
state: Toscana
city: Padova
country: Italy
facility: Universita degli studi di Padova Patologia e TIN ( Site 2305)
state: Veneto
city: Bari
country: Italy
facility: A.O. Policlinico Consorziale di Bari ( Site 2309)
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)
city: Maebashi
country: Japan
facility: Maebashi Red Cross Hospital ( Site 3057)
state: Gunma
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 3060)
state: Kanagawa
city: Yokohama
country: Japan
facility: JOHAS Yokohama Rosai Hospital ( Site 3058)
state: Kanagawa
city: Beppu
country: Japan
facility: National Hospital Organization Beppu Medical Center ( Site 3063)
state: Oita
city: Ageo
country: Japan
facility: Ageo Central General Hospital ( Site 3051)
state: Saitama
city: Yonago
country: Japan
facility: Tottori University Hospital ( Site 3053)
state: Tottori
city: Fukui
country: Japan
facility: Fukui Aiiku Hospital ( Site 3056)
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital ( Site 3064)
city: Saitama
country: Japan
facility: Saitama City Hospital ( Site 3055)
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital ( Site 3061)
city: Tokyo
country: Japan
facility: St.Luke's International Hospital ( Site 3062)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 3059)
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)
state: Incheon
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital ( Site 3210)
state: Jeonrabugdo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital ( Site 3212)
state: Kyonggi-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital ( Site 3207)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Pediatrics ( Site 3204)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 3206)
state: Pusan-Kwangyokshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital ( Site 3211)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3203)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 3201)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3202)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)
city: Kota Bahru
country: Malaysia
facility: Hospital Raja Perempuan Zainab II ( Site 3106)
state: Kelantan
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung ( Site 3103)
state: Perak
city: Taiping
country: Malaysia
facility: Hospital Taiping ( Site 3108)
state: Perak
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang ( Site 3104)
state: Pulau Pinang
city: Seberang Jaya
country: Malaysia
facility: Hospital Seberang Jaya ( Site 3107)
state: Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Sabah Womens & Childrens Hospital ( Site 3102)
state: Sabah
city: Sibu
country: Malaysia
facility: Hospital Sibu ( Site 3101)
state: Sarawak
city: Mexico
country: Mexico
facility: CAIMED Investigación en Salud S.A de C.V ( Site 1209)
state: Distrito Federal
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo ( Site 1204)
city: Huixquilucan
country: Mexico
facility: Hospital Angeles Lomas ( Site 1207)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria ( Site 1202)
city: Trujillo
country: Peru
facility: Clinica Peruano Americana S.A. ( Site 1253)
state: La Libertad
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica ( Site 1255)
state: Loreto
city: Lima
country: Peru
facility: Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)
city: Lima
country: Peru
facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)
city: Manila
country: Philippines
facility: University of the Philippines-Philippine General Hospital ( Site 3152)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Philippine Children s Medical Center ( Site 3154)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)
state: National Capital Region
city: Trzebnica
country: Poland
facility: Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: IN VIVO ( Site 2401)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)
state: Lodzkie
city: Leczna
country: Poland
facility: NZOZ Salmed ( Site 2433)
state: Lubelskie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)
state: Lubelskie
city: Krakow
country: Poland
facility: Centrum Medyczne PROMED ( Site 2432)
state: Malopolskie
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)
state: Malopolskie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia Warszawa ( Site 2438)
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 2437)
state: Pomorskie
city: Tychy
country: Poland
facility: Szpital Miejski w Tychach ( Site 2442)
state: Slaskie
city: Poznan
country: Poland
facility: Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)
state: Wielkopolskie
city: Mazowieckie
country: Poland
facility: MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)
city: Brasov
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)
city: Iasi
country: Romania
facility: Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)
city: Bloemfontein
country: South Africa
facility: University Of The Orange Free State ( Site 2507)
state: Free State
city: Johannesburg
country: South Africa
facility: Baragwanath Hospital ( Site 2501)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Empilweni Services and Research Unit ( Site 2504)
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital ( Site 2505)
state: Gauteng
city: Durban
country: South Africa
facility: Enhancing Care Foundation-DICRS ( Site 2506)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Tygerberg Hospital ( Site 2503)
state: Western Cape
city: Cape Town
country: South Africa
facility: MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)
state: Western Cape
city: Muang
country: Thailand
facility: Srinagarind Hospital. Khon Kaen University ( Site 3253)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Chulalongkorn University-Pediatrics ( Site 3252)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 3251)
state: Krung Thep Maha Nakhon
city: Hat Yai
country: Thailand
facility: Prince of Songkla University Faculty of Medicine ( Site 3255)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 3254)
city: Adana
country: Turkey
facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)
city: Ankara
country: Turkey
facility: Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty ( Site 2553)
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty-pediatric infection ( Site 2554)
city: Bristol
country: United Kingdom
facility: UH Bristol Education Centre ( Site 2607)
state: Bristol, City Of
city: London
country: United Kingdom
facility: St. Georges University Hospital NHS Foundation Trust ( Site 2601)
state: London, City Of
city: Belfast
country: United Kingdom
facility: Royal Maternity Hospital ( Site 2602)
state: Northern Ireland
city: Oxford
country: United Kingdom
facility: Oxford University Hospital NHS Foundation Trust ( Site 2604)
state: Oxfordshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.