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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04767373
Other study ID # 1654-004
Secondary ID MK-1654-004jRCT2
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 7, 2021
Est. completion date August 15, 2024

Study information

Verified date July 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3300
Est. completion date August 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Year
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections

Intervention

Biological:
Clesrovimab
Clesrovimab solution
Drug:
Placebo
Placebo (0.9% sodium chloride [NaCL]) solution

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Chile,  China,  Colombia,  Denmark,  Finland,  France,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Peru,  Philippines,  Poland,  Romania,  South Africa,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From Day 1 (postdose) to Day 150
Primary 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. From Day 1 (postdose) to Day 5
Primary 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. From Day 1 (postdose) to Day 5
Primary 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. From Day 1 (postdose) to Day 5
Primary 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. From Day 1 (postdose) to Day 42
Primary 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. From Day 1 (postdose) to Day 42
Primary 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. From Day 1 (postdose) to Day 42
Primary 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. Up to Day 515
Secondary 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. From Day 1 (postdose) to Day 150
Secondary 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. From Day 1 (postdose) to Day 180
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