Respiratory Syncytial Virus InfectionPhase 2/3CLEVERNCT04767373
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
A Phase 2/3 study testing Clesrovimab in people with Respiratory Syncytial Virus Infection, run by Merck Sharp & Dohme LLC at 217 sites in 24 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- Clesrovimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,632 participants
- Where
- 217 sitesin 24 countries
- Study dates
- 7 Apr 2021to 9 Jul 2024
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
217 sites in 24 countries.
217 sites in 24 countries
United States51 sites
Children's Hospital Colorado ( Site 0066)
Aurora, Colorado, 80045
Tekton Research ( Site 0080)
Chamblee, Georgia, 30341
Coastal Pediatric Research ( Site 0013)
Charleston, South Carolina, 29414
Pediatric Research of Charlottesville, LLC ( Site 0073)
Charlottesville, Virginia, 22902
MultiCare Rockwood Cheney Clinic ( Site 0068)
Cheney, Washington, 99004
Senders Pediatrics ( Site 0062)
Cleveland, Ohio, 44121
Optumcare Colorado Springs, LLC ( Site 0022)
Colorado Springs, Colorado, 80922
Ohio Pediatric Research Association ( Site 0063)
Dayton, Ohio, 45414
Southeastern Pediatric Associates, P.A. ( Site 0008)
Dothan, Alabama, 36303
Northwest Arkansas Pediatric Clinic ( Site 0050)
Fayetteville, Arkansas, 72703
Javara - Privia Medical Group North Texas - Frisco ( Site 0086)
Frisco, Texas, 75035
University of Texas Medical Branch at Galveston ( Site 0059)
Galveston, Texas, 77555
Tribe Clinical Research, LLC ( Site 0015)
Greenville, South Carolina, 29607
Meridian Clinical Research, LLC ( Site 0082)
Hastings, Nebraska, 68901
ACC Pediatric Research ( Site 0067)
Haughton, Louisiana, 71037
CCP- Kid's Way ( Site 0017)
Hermitage, Pennsylvania, 16148
Next Phase Research Alliance, LLC ( Site 0071)
Homestead, Florida, 33030
DM Clinical Research ( Site 0005)
Houston, Texas, 77065
Marshall University School of Medicine and Medical Center ( Site 0064)
Huntington, West Virginia, 25701
Clinical Research Prime ( Site 0075)
Idaho Falls, Idaho, 83404
Children's Clinic of Jonesboro, PA ( Site 0058)
Jonesboro, Arkansas, 72401
Alliance for Multispecialty Research, LLC ( Site 0092)
Kaysville, Utah, 84037
Holston Medical Group ( Site 0040)
Kingsport, Tennessee, 37660
FMC Science - Lampasas ( Site 0011)
Lampasas, Texas, 76550
Wee Care Pediatrics ( Site 0077)
Layton, Utah, 84041
Dartmouth-Hitchcock Medical Center ( Site 0031)
Lebanon, New Hampshire, 03756
Midwest Children's Health Research Institute, LLC ( Site 0044)
Lincoln, Nebraska, 68504
Long Beach Memorial Medical Center ( Site 0014)
Long Beach, California, 90806
DCOL Center for Clinical Research ( Site 0042)
Longview, Texas, 75605
Meridian Clinical Research, LLC ( Site 0083)
Macon, Georgia, 31210
Madera Family Medical Group ( Site 0046)
Madera, California, 93637
Marshfield Clinic ( Site 0054)
Marshfield, Wisconsin, 54449
Acevedo Clinical Research Associates ( Site 0002)
Miami, Florida, 33142
Cottonwood Pediatrics ( Site 0032)
Murray, Utah, 84107
Saltzer Medical Group ( Site 0004)
Nampa, Idaho, 83686
Rutgers University-Pediatric Clinical Research Center ( Site 0055)
New Brunswick, New Jersey, 08901
Orange County Research Institute ( Site 0057)
Ontario, California, 91762
UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)
Pittsburgh, Pennsylvania, 15213
Wee Care Pediatrics-Roy ( Site 0053)
Roy, Utah, 84067
University of Utah School of Medicine ( Site 0006)
Salt Lake City, Utah, 84108
University Health System- San Antonio ( Site 0048)
San Antonio, Texas, 78229
Private Practice - Dr. Etokhana ( Site 0089)
San Antonio, Texas, 78244
Road Runner Research, Ltd ( Site 0049)
San Antonio, Texas, 78249
Copperview Medical Center ( Site 0078)
South Jordan, Utah, 84095
Multicare Health System Institute for Research and Innovation ( Site 0025)
Spokane, Washington, 99202
Wee Care Pediatrics ( Site 0065)
Syracuse, Utah, 84075
Multicare Institute For Research And Innovation ( Site 0045)
Tacoma, Washington, 98405
Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)
Topeka, Kansas, 66604
Children's National Hospital ( Site 0076)
Washington D.C., District of Columbia, 20010
MedStar Georgetown Pediatrics ( Site 0047)
Washington D.C., District of Columbia, 20016
Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)
Winston-Salem, North Carolina, 27103
China30 sites
Peking University Third Hospital ( Site 3339)
Beijing, Beijing Municipality, 100091
Changde First People's Hospital ( Site 3311)
Changde, Hunan, 415000
The Maternal and Child Health Hospital of Hunan Province ( Site 3334)
Changsha, Hunan, 410000
Hunan Provincial People's Hospital ( Site 3355)
Changsha, Hunan, 410005
Xiangya Hospital Central South University ( Site 3347)
Changsha, Hunan, 410008
Chengdu Women and Children Center Hospital ( Site 3332)
Chengdu, Sichuan, 610091
The Children's Hospital of Chongqing Medical University ( Site 3333)
Chongqing, Chongqing Municipality, 400065
Jiangjin District Central Hospital ( Site 3319)
Chongqing, Chongqing Municipality, 402260
Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33
Dalian, Liaoning, 116012
Guangdong Provincial People's Hospital ( Site 3341)
Guangzhou, Guangdong, 510080
The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)
Guangzhou, Guangdong, 510150
Guangdong Maternity and Child Health Care Hospital ( Site 3340)
Guangzhou, Guangdong, 511400
The First People's Hospital of Hangzhou ( Site 3342)
Hangzhou, Zhejiang, 310006
Hebei Petro China Central Hospital ( Site 3365)
Langfang, Hebei, 065000
Linfen Central Hospital ( Site 3368)
Linfen, Shanxi, 041000
Linfen People's Hospital ( Site 3363)
Linfen, Shanxi, 041081
Liuzhou People's Hospital ( Site 3364)
Liuzhou, Guangxi, 545006
Jiangxi Provincial Children's Hospital ( Site 3313)
Nanchang, Jiangxi, 330006
The Third Hospital of Nanchang ( Site 3325)
Nanchang, Jiangxi, 330009
Zhongda Hospital Southeast University ( Site 3353)
Nanjing, Jiangsu, 210009
Ningbo Women and Children's Hospital ( Site 3314)
Ningbo, Zhejiang, 315012
Jiangxi Pingxiang People's Hospital ( Site 3312)
Pingxiang, Jiangxi, 337000
Sanmenxia Central Hospital ( Site 3360)
Sanmenxia, Henan, 472000
Children's Hospital of Fudan University ( Site 3361)
Shanghai, Shanghai Municipality, 201102
Hunan Shaoyang No.1 People's Hospital ( Site 3345)
Shaoyang, Hunan, 422000
Fourth Hospital of Hebei Medical University ( Site 3366)
Shijiazhuang, Hebei, 050035
Wuhan Children's Hospital ( Site 3329)
Wuhan, Hubei, 430000
Renmin Hospital of Wuhan University ( Site 3316)
Wuhan, Hubei, 430060
Xiamen Maternity and Child Health Care Hospital ( Site 3351)
Xiamen, Fujian, 361003
Yuncheng Central Hospital - Eastern Hospital ( Site 3318)
Yuncheng, Shanxi, 044000
Poland16 sites
IN VIVO ( Site 2401)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048
Uniwersyteckie Centrum Kliniczne ( Site 2437)
Gdansk, Pomeranian Voivodeship, 80-214
Centrum Medyczne PROMED ( Site 2432)
Krakow, Lesser Poland Voivodeship, 31-411
NZOZ Salmed ( Site 2433)
Łęczna, Lublin Voivodeship, 21-010
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)
Lodz, Łódź Voivodeship, 91-347
Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)
Lublin, Lublin Voivodeship, 20-093
MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)
Mazowieckie, Masovian Voivodeship, 02-972
Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)
Poznan, Greater Poland Voivodeship, 60-129
Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)
Tarnów, Lesser Poland Voivodeship, 33-100
Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)
Trzebnica, Lower Silesian Voivodeship, 55-100
Szpital Miejski w Tychach ( Site 2442)
Tychy, Silesian Voivodeship, 43-100
Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)
Warsaw, Masovian Voivodeship, 00-315
WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)
Warsaw, Masovian Voivodeship, 00-728
Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)
Warsaw, Masovian Voivodeship, 01-809
Centrum Medyczne Pratia Warszawa ( Site 2438)
Warsaw, Masovian Voivodeship, 01-868
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)
Wroclaw, Lower Silesian Voivodeship, 50-368
Japan12 sites
Ageo Central General Hospital ( Site 3051)
Ageo, Saitama, 362-8588
National Hospital Organization Beppu Medical Center ( Site 3063)
Beppu, Oita Prefecture
Fukui Aiiku Hospital ( Site 3056)
Fukui, 910-0833
Fukui-ken Saiseikai Hospital ( Site 3064)
Fukui, 918-8503
St. Marianna University School of Medicine Hospital ( Site 3060)
Kawasaki, Kanagawa, 216-8511
Maebashi Red Cross Hospital ( Site 3057)
Maebashi, Gunma, 371-0811
Saitama City Hospital ( Site 3055)
Saitama, 336-8522
Shizuoka City Shimizu Hospital ( Site 3061)
Shizuoka, 424-8636
St.Luke's International Hospital ( Site 3062)
Tokyo, 104-8560
Showa University Hospital ( Site 3059)
Tokyo, 142-8666
JOHAS Yokohama Rosai Hospital ( Site 3058)
Yokohama, Kanagawa, 222-0036
Tottori University Hospital ( Site 3053)
Yonago, Tottori, 683-8504
South Korea11 sites
Korea University Ansan Hospital ( Site 3212)
Ansan-si, Kyonggi-do, 15355
Hallym University Sacred Heart Hospital ( Site 3207)
Anyang, Kyonggi-do, 14068
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)
Bupyeong-gu, Incheon, 21431
Pusan National University Hospital ( Site 3206)
Busan, Pusan-Kwangyokshi, 49241
Chungang University Hospital ( Site 3211)
Dongjak-gu, Seoul, 06973
Jeonbuk National University Hospital ( Site 3210)
Jeonju, Jeonrabugdo, 54907
Seoul National University Bundang Hospital-Pediatrics ( Site 3204)
Seongnam, Kyonggi-do, 13620
Seoul National University Hospital ( Site 3203)
Seoul, 03080
Severance Hospital Yonsei University Health System ( Site 3201)
Seoul, 03722
Samsung Medical Center ( Site 3202)
Seoul, 06351
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)
Seoul, 06591
Finland10 sites
FVR, Espoon rokotetutkimusklinikka ( Site 2152)
Espoo, Uusimaa, 02230
FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)
Helsinki, Uusimaa, 00100
FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)
Helsinki, Uusimaa, 00930
FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)
Jarvenpaa, Uusimaa, 04400
FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)
Kokkola, Keski-Pohjanmaa, 67100
FVR, Oulun rokotetutkimusklinikka ( Site 2158)
Oulu, North Ostrobothnia, 90220
FVR, Porin rokotetutkimusklinikka ( Site 2156)
Pori, Satakunta, 28100
FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)
Seinäjoki, South Ostrobothnia, 60100
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)
Tampere, Pirkanmaa, 33100
FVR, Turun rokotetutkimusklinikka ( Site 2151)
Turku, Southwest Finland, 20520
Canada7 sites
University of Calgary - Alberta Children Hospital ( Site 0504)
Calgary, Alberta, T3B 6A8
Canadian Center for Vaccinology ( Site 0503)
Halifax, Nova Scotia, B3K 6R8
Hamilton Medical Research Group ( Site 0509)
Hamilton, Ontario, L8M 1K7
CHU Sainte Justine ( Site 0502)
Montreal, Quebec, H3T 1C5
McGill University Health Centre - Vaccine Study Centre ( Site 0500)
Pierrefonds, Quebec, H9H 4Y6
CHU de Quebec Universite de Laval ( Site 0501)
Québec, Quebec, G1E 7G9
BC Women s Hospital and Health Centre ( Site 0506)
Vancouver, British Columbia, V6H 3N1
Malaysia7 sites
Hospital Pulau Pinang ( Site 3104)
George Town, Pulau Pinang, 10990
Hospital Raja Perempuan Zainab II ( Site 3106)
Kota Bharu, Kelantan, 15586
Sabah Womens & Childrens Hospital ( Site 3102)
Kota Kinabalu, Sabah, 88996
Hospital Seberang Jaya ( Site 3107)
Seberang Jaya, Pulau Pinang, 13700
Hospital Seri Manjung ( Site 3103)
Seri Manjung, Perak, 32040
Hospital Sibu ( Site 3101)
Sibu, Sarawak, 96000
Hospital Taiping ( Site 3108)
Taiping, Perak, 34000
South Africa7 sites
University Of The Orange Free State ( Site 2507)
Bloemfontein, Free State, 9301
Tygerberg Hospital ( Site 2503)
Cape Town, Western Cape, 7505
MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)
Cape Town, Western Cape, 7700
Enhancing Care Foundation-DICRS ( Site 2506)
Durban, KwaZulu-Natal, 4013
Baragwanath Hospital ( Site 2501)
Johannesburg, Gauteng, 2013
Empilweni Services and Research Unit ( Site 2504)
Johannesburg, Gauteng, 2093
Steve Biko Academic Hospital ( Site 2505)
Pretoria, Gauteng, 0002
Argentina5 sites
SANATORIO MATER DEI ( Site 1010)
Buenos Aires, C1425DND
Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426BOS
SANATORIO DEL SALVADOR-Pediatria ( Site 1008)
Córdoba, Córdoba Province, 5004
Clinica Privada del Sol S.A ( Site 1013)
Córdoba, X5000IIH
Clinica del Nino y la Madre ( Site 1005)
Mar de La Plata, Buenos Aires, B7600FYH
Belgium5 sites
Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)
Brussels, Bruxelles-Capitale, Region de, 1000
Cliniques Universitaires Saint-Luc ( Site 2005)
Brussels, Bruxelles-Capitale, Region de, 1200
Universitair Ziekenhuis Antwerpen ( Site 2001)
Edegem, Antwerpen, 2650
Cabinet Médical Demeulemeester ( Site 2002)
Gozée, Wallonne, Region, 6534
AZ Delta ( Site 2004)
Roeselare, West-Vlaanderen, 8800
Colombia5 sites
Clinica de la Costa S.A.S. ( Site 1152)
Barranquilla, Atlántico, 080020
Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)
Cali, Valle del Cauca Department, 760001
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)
Chía, Cundinamarca, 250001
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)
Medellín, Antioquia, 050036
Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)
Rionegro, Antioquia, 054040
Israel5 sites
Soroka Medical Center ( Site 2351)
Beersheba, 8410101
Soroka University Medical Center Ramot Family health center ( Site 2354)
Beersheba, 8471844
Rambam Medical Center ( Site 2352)
Haifa, 3525408
Soroka University Medical Center Rahat Family health center ( Site 2355)
Rahat, 8535700
Chaim Sheba Medical Center ( Site 2353)
Ramat Gan, 5265601
Italy5 sites
A.O. Policlinico Consorziale di Bari ( Site 2309)
Bari, 70124
A.O.Universitaria Meyer ( Site 2306)
Florence, Tuscany, 50139
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)
Milan, 20122
Universita degli studi di Padova Patologia e TIN ( Site 2305)
Padova, Veneto, 35128
Policlinico Universitario Gemelli ( Site 2301)
Rome, Roma, 00168
Thailand5 sites
Chulalongkorn University-Pediatrics ( Site 3252)
Bangkok, Bangkok, 10330
Siriraj Hospital ( Site 3251)
Bangkok, Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital ( Site 3254)
Chiang Mai, 50200
Prince of Songkla University Faculty of Medicine ( Site 3255)
Hat Yai, Changwat Songkhla, 90110
Srinagarind Hospital. Khon Kaen University ( Site 3253)
Muang, Changwat Khon Kaen, 40002
Turkey (Türkiye)5 sites
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)
Adana, 01330
Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)
Ankara, 06560
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)
Ankara, 06590
Ege University Medical Faculty ( Site 2553)
Izmir, 35100
Erciyes University Medical Faculty-pediatric infection ( Site 2554)
Kayseri, 38039
United Kingdom5 sites
Royal Maternity Hospital ( Site 2602)
Belfast, Northern Ireland, BT12 6BB
UH Bristol Education Centre ( Site 2607)
Bristol, Bristol, City of, BS2 8AE
Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)
Liverpool, L12 2AP
St. Georges University Hospital NHS Foundation Trust ( Site 2601)
London, London, City of, SW17 0QT
Oxford University Hospital NHS Foundation Trust ( Site 2604)
Oxford, Oxfordshire, OX3 9DU
Chile4 sites
Hospital La Florida ( Site 1104)
Santiago, Region M. de Santiago, 8242238
Hospital Roberto del Rio ( Site 1106)
Santiago, Region M. de Santiago, 8380418
Facultad Medicina Universidad de Chile ( Site 1105)
Santiago, Region M. de Santiago, 8380453
Hospital Padre Hurtado ( Site 1101)
Santiago, Region M. de Santiago, 8880465
Denmark4 sites
Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)
Aalborg, North Denmark, 9000
Regionshospitalet Herning ( Site 2105)
Herning, Central Jutland, 7400
Regionshospitalet Nordjylland ( Site 2102)
Hjørring, North Denmark, 9800
Odense University Hospital ( Site 2107)
Odense, Region Syddanmark, 5000
Mexico4 sites
Centenario Hospital Miguel Hidalgo ( Site 1204)
Aguascalientes, 20259
Hospital Angeles Lomas ( Site 1207)
Huixquilucan, 52763
CAIMED Investigación en Salud S.A de C.V ( Site 1209)
Mexico City, Mexico City, 06760
Instituto Nacional de Pediatria ( Site 1202)
Mexico City, 04530
Peru4 sites
Asociacion Civil Selva Amazonica ( Site 1255)
Iquitos, Loreto, 16001
Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)
Lima, 15001
Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)
Lima, LIMA 36
Clinica Peruano Americana S.A. ( Site 1253)
Trujillo, La Libertad, 13011
Romania4 sites
Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)
Brasov, 500063
Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)
Bucharest, 011171
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)
Constanța, 900591
Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)
Iași, 700038
France3 sites
Groupe Hospitalier Pellegrin ( Site 2218)
Bordeaux, Gironde, 33000
CHU Caen ( Site 2212)
Caen, Calvados, 14033
Centre Hospitalier de Versailles ( Site 2206)
Le Chesnay, Yvelines, 78150
Philippines3 sites
University of the Philippines-Philippine General Hospital ( Site 3152)
Manila, National Capital Region, 1000
Philippine Children s Medical Center ( Site 3154)
Quezon City, National Capital Region, 1100
Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)
Quezon City, National Capital Region, 1118
About this study
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
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
- Being tested
- Clesrovimab, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClesrovimabBiological
Also called MK-1654
Clesrovimab solution
PlaceboDrug
Placebo (0.9% sodium chloride [NaCL]) solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR nasopharyngeal sample. Per protocol, the number of participants with RSV-associated hospitalization were reported for RSV season 1.
Measured: From Day 1 (postdose) to Day 150
RSV Season 1: Number of Participants With RSV-Associated 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 RT-PCR nasopharyngeal sample. Per protocol, participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Measured: From Day 1 (postdose) to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start7 Apr 2021
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767373
- Sponsor's protocol ID
- 1654-004
- Other IDs
- MK-1654-004, jRCT2051210019, PHRR210706-003684, 2022-500350-42-00, U1111-1275-5918, 2020-002405-26
- Acronym
- CLEVER
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2021
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 40961446He Y, Zhao F, Yang X, Xing S, Xi F, Shen F, Yang L, Ning G, Sun F, Wang R, Shou Q, Fu R, Chen C, Sinha A, Liao X. Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants. Hum Vaccin Immunother. 2025 Dec;21(1):2516948. doi: 10.1080/21645515.2025.2516948. Epub 2025 Jul 17.
PubMed 40673795Ginsburg 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.
PubMed 34774184