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

NCT04767373 | Completed Phase 2 Results DMC FDA Drug

• 7 other identifiers: 1654-004MK-1654-004jRCT2051210019PHRR210706-0036842022-500350-42-00U1111-1275-59182020-002405-26
• Study Type: interventional
• Target: 3,632
• Locations: 24 countries
• Sites: 217

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.

Conditions

Respiratory Syncytial Virus Infection

Outcome Measures

Primary Outcomes (8)

• RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)

  Outpatient and inpatient MALRI was 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 due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.

  From Day 1 (postdose) to Day 150

• RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)

  An AE was 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. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.

  From Day 1 (postdose) to Day 5

• RSV Season 1: Percentage of Participants With Fever

  Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.

  From Day 1 (postdose) to Day 5

• RSV Season 1: Percentage of Participants With Solicited Systemic AEs

  An AE was 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. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.

  From Day 1 (postdose) to Day 5

• RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)

  An AE was 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. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.

  From Day 1 (postdose) to Day 42

• RSV Season 1: Percentage of Participants With Rash AESI

  An AE was 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. Rash AESI included acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.

  From Day 1 (postdose) to Day 42

• RSV Season 1: Percentage of Participants With ≥1 Nonserious AE

  An AE was 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. Per protocol, the percentage of RSV season 1 participants with ≥1 nonserious AE were reported.

  From Day 1 (postdose) to Day 42

• Percentage of Participants With Serious Adverse Events (SAEs)

  An SAE was 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. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.

  RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515

Secondary Outcomes (2)

• RSV Season 1: Number of Participants With RSV-Associated Hospitalization

  From Day 1 (postdose) to Day 150

• RSV Season 1: Number of Participants With RSV-Associated MALRI

  From Day 1 (postdose) to Day 180

Study Arms (2)

Clesrovimab 105 mg

EXPERIMENTAL

Participants receive a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.

Biological: Clesrovimab

Placebo

PLACEBO COMPARATOR

Participants receive a single IM administration of placebo on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.

Drug: Placebo

Interventions

Clesrovimab BIOLOGICAL

Clesrovimab solution

Also known as: MK-1654

Clesrovimab 105 mg

Placebo DRUG

Placebo (0.9% sodium chloride \[NaCL\]) solution

Placebo

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (217)

Southeastern Pediatric Associates, P.A. ( Site 0008)

Dothan, Alabama, 36303, United States

Location

Northwest Arkansas Pediatric Clinic ( Site 0050)

Fayetteville, Arkansas, 72703, United States

Location

Children's Clinic of Jonesboro, PA ( Site 0058)

Jonesboro, Arkansas, 72401, United States

Location

Long Beach Memorial Medical Center ( Site 0014)

Long Beach, California, 90806, United States

Location

Madera Family Medical Group ( Site 0046)

Madera, California, 93637, United States

Location

Orange County Research Institute ( Site 0057)

Ontario, California, 91762, United States

Location

Children's Hospital Colorado ( Site 0066)

Aurora, Colorado, 80045, United States

Location

Optumcare Colorado Springs, LLC ( Site 0022)

Colorado Springs, Colorado, 80922, United States

Location

Children's National Hospital ( Site 0076)

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Georgetown Pediatrics ( Site 0047)

Washington D.C., District of Columbia, 20016, United States

Location

Next Phase Research Alliance, LLC ( Site 0071)

Homestead, Florida, 33030, United States

Location

Acevedo Clinical Research Associates ( Site 0002)

Miami, Florida, 33142, United States

Location

Tekton Research ( Site 0080)

Chamblee, Georgia, 30341, United States

Location

Meridian Clinical Research, LLC ( Site 0083)

Macon, Georgia, 31210, United States

Location

Clinical Research Prime ( Site 0075)

Idaho Falls, Idaho, 83404, United States

Location

Saltzer Medical Group ( Site 0004)

Nampa, Idaho, 83686, United States

Location

Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)

Topeka, Kansas, 66604, United States

Location

ACC Pediatric Research ( Site 0067)

Haughton, Louisiana, 71037, United States

Location

Meridian Clinical Research, LLC ( Site 0082)

Hastings, Nebraska, 68901, United States

Location

Midwest Children's Health Research Institute, LLC ( Site 0044)

Lincoln, Nebraska, 68504, United States

Location

Dartmouth-Hitchcock Medical Center ( Site 0031)

Lebanon, New Hampshire, 03756, United States

Location

Rutgers University-Pediatric Clinical Research Center ( Site 0055)

New Brunswick, New Jersey, 08901, United States

Location

Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)

Winston-Salem, North Carolina, 27103, United States

Location

Senders Pediatrics ( Site 0062)

Cleveland, Ohio, 44121, United States

Location

Ohio Pediatric Research Association ( Site 0063)

Dayton, Ohio, 45414, United States

Location

CCP- Kid's Way ( Site 0017)

Hermitage, Pennsylvania, 16148, United States

Location

UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)

Pittsburgh, Pennsylvania, 15213, United States

Location

Coastal Pediatric Research ( Site 0013)

Charleston, South Carolina, 29414, United States

Location

Tribe Clinical Research, LLC ( Site 0015)

Greenville, South Carolina, 29607, United States

Location

Holston Medical Group ( Site 0040)

Kingsport, Tennessee, 37660, United States

Location

Javara - Privia Medical Group North Texas - Frisco ( Site 0086)

Frisco, Texas, 75035, United States

Location

University of Texas Medical Branch at Galveston ( Site 0059)

Galveston, Texas, 77555, United States

Location

DM Clinical Research ( Site 0005)

Houston, Texas, 77065, United States

Location

FMC Science - Lampasas ( Site 0011)

Lampasas, Texas, 76550, United States

Location

DCOL Center for Clinical Research ( Site 0042)

Longview, Texas, 75605, United States

Location

University Health System- San Antonio ( Site 0048)

San Antonio, Texas, 78229, United States

Location

Private Practice - Dr. Etokhana ( Site 0089)

San Antonio, Texas, 78244, United States

Location

Road Runner Research, Ltd ( Site 0049)

San Antonio, Texas, 78249, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0092)

Kaysville, Utah, 84037, United States

Location

Wee Care Pediatrics ( Site 0077)

Layton, Utah, 84041, United States

Location

Cottonwood Pediatrics ( Site 0032)

Murray, Utah, 84107, United States

Location

Wee Care Pediatrics-Roy ( Site 0053)

Roy, Utah, 84067, United States

Location

University of Utah School of Medicine ( Site 0006)

Salt Lake City, Utah, 84108, United States

Location

Copperview Medical Center ( Site 0078)

South Jordan, Utah, 84095, United States

Location

Wee Care Pediatrics ( Site 0065)

Syracuse, Utah, 84075, United States

Location

Pediatric Research of Charlottesville, LLC ( Site 0073)

Charlottesville, Virginia, 22902, United States

Location

MultiCare Rockwood Cheney Clinic ( Site 0068)

Cheney, Washington, 99004, United States

Location

Multicare Health System Institute for Research and Innovation ( Site 0025)

Spokane, Washington, 99202, United States

Location

Multicare Institute For Research And Innovation ( Site 0045)

Tacoma, Washington, 98405, United States

Location

Marshall University School of Medicine and Medical Center ( Site 0064)

Huntington, West Virginia, 25701, United States

Location

Marshfield Clinic ( Site 0054)

Marshfield, Wisconsin, 54449, United States

Location

Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426BOS, Argentina

Location

Clinica del Nino y la Madre ( Site 1005)

Mar de La Plata, Buenos Aires, B7600FYH, Argentina

Location

SANATORIO DEL SALVADOR-Pediatria ( Site 1008)

Córdoba, Córdoba Province, 5004, Argentina

Location

SANATORIO MATER DEI ( Site 1010)

Buenos Aires, C1425DND, Argentina

Location

Clinica Privada del Sol S.A ( Site 1013)

Córdoba, X5000IIH, Argentina

Location

Universitair Ziekenhuis Antwerpen ( Site 2001)

Edegem, Antwerpen, 2650, Belgium

Location

Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)

Brussels, Bruxelles-Capitale, Region de, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc ( Site 2005)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

Cabinet Médical Demeulemeester ( Site 2002)

Gozée, Wallonne, Region, 6534, Belgium

Location

AZ Delta ( Site 2004)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

University of Calgary - Alberta Children Hospital ( Site 0504)

Calgary, Alberta, T3B 6A8, Canada

Location

BC Women s Hospital and Health Centre ( Site 0506)

Vancouver, British Columbia, V6H 3N1, Canada

Location

Canadian Center for Vaccinology ( Site 0503)

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hamilton Medical Research Group ( Site 0509)

Hamilton, Ontario, L8M 1K7, Canada

Location

CHU Sainte Justine ( Site 0502)

Montreal, Quebec, H3T 1C5, Canada

Location

McGill University Health Centre - Vaccine Study Centre ( Site 0500)

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

CHU de Quebec Universite de Laval ( Site 0501)

Québec, Quebec, G1E 7G9, Canada

Location

Hospital La Florida ( Site 1104)

Santiago, Region M. de Santiago, 8242238, Chile

Location

Hospital Roberto del Rio ( Site 1106)

Santiago, Region M. de Santiago, 8380418, Chile

Location

Facultad Medicina Universidad de Chile ( Site 1105)

Santiago, Region M. de Santiago, 8380453, Chile

Location

Hospital Padre Hurtado ( Site 1101)

Santiago, Region M. de Santiago, 8880465, Chile

Location

Peking University Third Hospital ( Site 3339)

Beijing, Beijing Municipality, 100091, China

Location

The Children's Hospital of Chongqing Medical University ( Site 3333)

Chongqing, Chongqing Municipality, 400065, China

Location

Jiangjin District Central Hospital ( Site 3319)

Chongqing, Chongqing Municipality, 402260, China

Location

Xiamen Maternity and Child Health Care Hospital ( Site 3351)

Xiamen, Fujian, 361003, China

Location

Guangdong Provincial People's Hospital ( Site 3341)

Guangzhou, Guangdong, 510080, China

Location

The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)

Guangzhou, Guangdong, 510150, China

Location

Guangdong Maternity and Child Health Care Hospital ( Site 3340)

Guangzhou, Guangdong, 511400, China

Location

Liuzhou People's Hospital ( Site 3364)

Liuchow, Guangxi, 545006, China

Location

Hebei Petro China Central Hospital ( Site 3365)

Langfang, Hebei, 065000, China

Location

Fourth Hospital of Hebei Medical University ( Site 3366)

Shijiazhuang, Hebei, 050035, China

Location

Sanmenxia Central Hospital ( Site 3360)

Sanmenxia, Henan, 472000, China

Location

Wuhan Children's Hospital ( Site 3329)

Wuhan, Hubei, 430000, China

Location

Renmin Hospital of Wuhan University ( Site 3316)

Wuhan, Hubei, 430060, China

Location

Changde First People's Hospital ( Site 3311)

Changde, Hunan, 415000, China

Location

The Maternal and Child Health Hospital of Hunan Province ( Site 3334)

Changsha, Hunan, 410000, China

Location

Hunan Provincial People's Hospital ( Site 3355)

Changsha, Hunan, 410005, China

Location

Xiangya Hospital Central South University ( Site 3347)

Changsha, Hunan, 410008, China

Location

Hunan Shaoyang No.1 People's Hospital ( Site 3345)

Shaoyang, Hunan, 422000, China

Location

Zhongda Hospital Southeast University ( Site 3353)

Nanjing, Jiangsu, 210009, China

Location

Jiangxi Provincial Children's Hospital ( Site 3313)

Nanchang, Jiangxi, 330006, China

Location

The Third Hospital of Nanchang ( Site 3325)

Nanchang, Jiangxi, 330009, China

Location

Jiangxi Pingxiang People's Hospital ( Site 3312)

Pingxiang, Jiangxi, 337000, China

Location

Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33

Dalian, Liaoning, 116012, China

Location

Children's Hospital of Fudan University ( Site 3361)

Shanghai, Shanghai Municipality, 201102, China

Location

Linfen Central Hospital ( Site 3368)

Linfen, Shanxi, 041000, China

Location

Linfen People's Hospital ( Site 3363)

Linfen, Shanxi, 041081, China

Location

Yuncheng Central Hospital - Eastern Hospital ( Site 3318)

Yuncheng, Shanxi, 044000, China

Location

Chengdu Women and Children Center Hospital ( Site 3332)

Chengdu, Sichuan, 610091, China

Location

The First People's Hospital of Hangzhou ( Site 3342)

Hangzhou, Zhejiang, 310006, China

Location

Ningbo Women and Children's Hospital ( Site 3314)

Ningbo, Zhejiang, 315012, China

Location

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)

Medellín, Antioquia, 050036, Colombia

Location

Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)

Rionegro, Antioquia, 054040, Colombia

Location

Clinica de la Costa S.A.S. ( Site 1152)

Barranquilla, Atlántico, 080020, Colombia

Location

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)

Chía, Cundinamarca, 250001, Colombia

Location

Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)

Cali, Valle del Cauca Department, 760001, Colombia

Location

Regionshospitalet Herning ( Site 2105)

Herning, Central Jutland, 7400, Denmark

Location

Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)

Aalborg, North Denmark, 9000, Denmark

Location

Regionshospitalet Nordjylland ( Site 2102)

Hjørring, North Denmark, 9800, Denmark

Location

Odense University Hospital ( Site 2107)

Odense, Region Syddanmark, 5000, Denmark

Location

FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

FVR, Oulun rokotetutkimusklinikka ( Site 2158)

Oulu, North Ostrobothnia, 90220, Finland

Location

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)

Tampere, Pirkanmaa, 33100, Finland

Location

FVR, Porin rokotetutkimusklinikka ( Site 2156)

Pori, Satakunta, 28100, Finland

Location

FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

FVR, Turun rokotetutkimusklinikka ( Site 2151)

Turku, Southwest Finland, 20520, Finland

Location

FVR, Espoon rokotetutkimusklinikka ( Site 2152)

Espoo, Uusimaa, 02230, Finland

Location

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)

Helsinki, Uusimaa, 00100, Finland

Location

FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)

Helsinki, Uusimaa, 00930, Finland

Location

FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)

Jarvenpaa, Uusimaa, 04400, Finland

Location

CHU Caen ( Site 2212)

Caen, Calvados, 14033, France

Location

Groupe Hospitalier Pellegrin ( Site 2218)

Bordeaux, Gironde, 33000, France

Location

Centre Hospitalier de Versailles ( Site 2206)

Le Chesnay, Yvelines, 78150, France

Location

Soroka Medical Center ( Site 2351)

Beersheba, 8410101, Israel

Location

Soroka University Medical Center Ramot Family health center ( Site 2354)

Beersheba, 8471844, Israel

Location

Rambam Medical Center ( Site 2352)

Haifa, 3525408, Israel

Location

Soroka University Medical Center Rahat Family health center ( Site 2355)

Rahat, 8535700, Israel

Location

Chaim Sheba Medical Center ( Site 2353)

Ramat Gan, 5265601, Israel

Location

Policlinico Universitario Gemelli ( Site 2301)

Rome, Roma, 00168, Italy

Location

A.O.Universitaria Meyer ( Site 2306)

Florence, Tuscany, 50139, Italy

Location

Universita degli studi di Padova Patologia e TIN ( Site 2305)

Padua, Veneto, 35128, Italy

Location

A.O. Policlinico Consorziale di Bari ( Site 2309)

Bari, 70124, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)

Milan, 20122, Italy

Location

Maebashi Red Cross Hospital ( Site 3057)

Maebashi, Gunma, 371-0811, Japan

Location

St. Marianna University School of Medicine Hospital ( Site 3060)

Kawasaki, Kanagawa, 216-8511, Japan

Location

JOHAS Yokohama Rosai Hospital ( Site 3058)

Yokohama, Kanagawa, 222-0036, Japan

Location

National Hospital Organization Beppu Medical Center ( Site 3063)

Beppu, Oita Prefecture, Japan

Location

Ageo Central General Hospital ( Site 3051)

Ageo, Saitama, 362-8588, Japan

Location

Tottori University Hospital ( Site 3053)

Yonago, Tottori, 683-8504, Japan

Location

Fukui Aiiku Hospital ( Site 3056)

Fukui, 910-0833, Japan

Location

Fukui-ken Saiseikai Hospital ( Site 3064)

Fukui, 918-8503, Japan

Location

Saitama City Hospital ( Site 3055)

Saitama, 336-8522, Japan

Location

Shizuoka City Shimizu Hospital ( Site 3061)

Shizuoka, 424-8636, Japan

Location

St.Luke's International Hospital ( Site 3062)

Tokyo, 104-8560, Japan

Location

Showa University Hospital ( Site 3059)

Tokyo, 142-8666, Japan

Location

Hospital Raja Perempuan Zainab II ( Site 3106)

Kota Bharu, Kelantan, 15586, Malaysia

Location

Hospital Seri Manjung ( Site 3103)

Seri Manjung, Perak, 32040, Malaysia

Location

Hospital Taiping ( Site 3108)

Taiping, Perak, 34000, Malaysia

Location

Hospital Pulau Pinang ( Site 3104)

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Seberang Jaya ( Site 3107)

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Sabah Womens & Childrens Hospital ( Site 3102)

Kota Kinabalu, Sabah, 88996, Malaysia

Location

Hospital Sibu ( Site 3101)

Sibu, Sarawak, 96000, Malaysia

Location

CAIMED Investigación en Salud S.A de C.V ( Site 1209)

Mexico City, Mexico City, 06760, Mexico

Location

Centenario Hospital Miguel Hidalgo ( Site 1204)

Aguascalientes, 20259, Mexico

Location

Hospital Angeles Lomas ( Site 1207)

Huixquilucan, 52763, Mexico

Location

Instituto Nacional de Pediatria ( Site 1202)

Mexico City, 04530, Mexico

Location

Clinica Peruano Americana S.A. ( Site 1253)

Trujillo, La Libertad, 13011, Peru

Location

Asociacion Civil Selva Amazonica ( Site 1255)

Iquitos, Loreto, 16001, Peru

Location

Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)

Lima, 15001, Peru

Location

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)

Lima, LIMA 36, Peru

Location

University of the Philippines-Philippine General Hospital ( Site 3152)

Manila, National Capital Region, 1000, Philippines

Location

Philippine Children s Medical Center ( Site 3154)

Quezon City, National Capital Region, 1100, Philippines

Location

Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)

Quezon City, National Capital Region, 1118, Philippines

Location

Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)

Poznan, Greater Poland Voivodeship, 60-129, Poland

Location

IN VIVO ( Site 2401)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Centrum Medyczne PROMED ( Site 2432)

Krakow, Lesser Poland Voivodeship, 31-411, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

Location

Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)

Lublin, Lublin Voivodeship, 20-093, Poland

Location

NZOZ Salmed ( Site 2433)

Łęczna, Lublin Voivodeship, 21-010, Poland

Location

MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)

Mazowieckie, Masovian Voivodeship, 02-972, Poland

Location

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)

Warsaw, Masovian Voivodeship, 00-315, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)

Warsaw, Masovian Voivodeship, 01-809, Poland

Location

Centrum Medyczne Pratia Warszawa ( Site 2438)

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Uniwersyteckie Centrum Kliniczne ( Site 2437)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Szpital Miejski w Tychach ( Site 2442)

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)

Lodz, Łódź Voivodeship, 91-347, Poland

Location

Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)

Brasov, 500063, Romania

Location

Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)

Bucharest, 011171, Romania

Location

Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)

Constanța, 900591, Romania

Location

Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)

Iași, 700038, Romania

Location

University Of The Orange Free State ( Site 2507)

Bloemfontein, Free State, 9301, South Africa

Location

Baragwanath Hospital ( Site 2501)

Johannesburg, Gauteng, 2013, South Africa

Location

Empilweni Services and Research Unit ( Site 2504)

Johannesburg, Gauteng, 2093, South Africa

Location

Steve Biko Academic Hospital ( Site 2505)

Pretoria, Gauteng, 0002, South Africa

Location

Enhancing Care Foundation-DICRS ( Site 2506)

Durban, KwaZulu-Natal, 4013, South Africa

Location

Tygerberg Hospital ( Site 2503)

Cape Town, Western Cape, 7505, South Africa

Location

MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)

Cape Town, Western Cape, 7700, South Africa

Location

The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)

Bupyeong-gu, Incheon, 21431, South Korea

Location

Jeonbuk National University Hospital ( Site 3210)

Jeonju, Jeonrabugdo, 54907, South Korea

Location

Korea University Ansan Hospital ( Site 3212)

Ansan-si, Kyonggi-do, 15355, South Korea

Location

Hallym University Sacred Heart Hospital ( Site 3207)

Anyang, Kyonggi-do, 14068, South Korea

Location

Seoul National University Bundang Hospital-Pediatrics ( Site 3204)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Pusan National University Hospital ( Site 3206)

Busan, Pusan-Kwangyokshi, 49241, South Korea

Location

Chungang University Hospital ( Site 3211)

Dongjak-gu, Seoul, 06973, South Korea

Location

Seoul National University Hospital ( Site 3203)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 3201)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 3202)

Seoul, 06351, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)

Seoul, 06591, South Korea

Location

Chulalongkorn University-Pediatrics ( Site 3252)

Bangkok, Bangkok, 10330, Thailand

Location

Siriraj Hospital ( Site 3251)

Bangkok, Bangkok, 10700, Thailand

Location

Srinagarind Hospital. Khon Kaen University ( Site 3253)

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Prince of Songkla University Faculty of Medicine ( Site 3255)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 3254)

Chiang Mai, 50200, Thailand

Location

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)

Adana, 01330, Turkey (Türkiye)

Location

Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)

Ankara, 06590, Turkey (Türkiye)

Location

Ege University Medical Faculty ( Site 2553)

Izmir, 35100, Turkey (Türkiye)

Location

Erciyes University Medical Faculty-pediatric infection ( Site 2554)

Kayseri, 38039, Turkey (Türkiye)

Location

UH Bristol Education Centre ( Site 2607)

Bristol, Bristol, City of, BS2 8AE, United Kingdom

Location

St. Georges University Hospital NHS Foundation Trust ( Site 2601)

London, London, City of, SW17 0QT, United Kingdom

Location

Royal Maternity Hospital ( Site 2602)

Belfast, Northern Ireland, BT12 6BB, United Kingdom

Location

Oxford University Hospital NHS Foundation Trust ( Site 2604)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)

Liverpool, L12 2AP, United Kingdom

Location

Related Publications (2)

• Zar HJ, Simoes EAF, Madhi SA, Ramilo O, Senders SD, Shepard JS, Laoprasopwattana K, Piedrahita J, Novoa JM, Vargas SL, Dionne M, Jackowska T, Liu E, Ishihara Y, Ikeda K, Zhang Y, Railkar RA, Lutkiewicz J, Vora KA, Zang X, Maas BM, Lee AW, Guerra A, Sinha A; CLEVER (MK-1654-004) Study Group. Clesrovimab for Prevention of RSV Disease in Healthy Infants. N Engl J Med. 2025 Oct 2;393(13):1292-1303. doi: 10.1056/NEJMoa2502984. Epub 2025 Sep 17.

  PMID: 40961446 DERIVED

• 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.

  PMID: 34774184 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

MK-1654

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 23, 2021
• Study Start: April 7, 2021
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: February 11, 2026
• Results First Posted: February 4, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (5); GB (5); PE (4); KR (11); JP (12); AR (5); RO (4); MY (7); DK (4); ZA (7); US (51); FI (10); CN (30); CA (7); CL (4); ME (4); TH (5); PH (3); PL (16); BE (5); CO (5); IT (5); IL (5); FR (3)