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

Respiratory Syncytial Virus Infection Clinical Trial

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

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
• 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
• 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

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

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary