MK-1654 in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04938830
Collaborator
(none)
1,000
77
2
52.9
13
0.2
Study Details
Study Description
Brief Summary
This study aims to evaluate the safety and tolerability of MK-1654 compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Actual Study Start Date
:
Nov 30, 2021
Anticipated Primary Completion Date
:
Aug 21, 2025
Anticipated Study Completion Date
:
Apr 27, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MK-1654 Participants will receive intramuscular (IM) injections of MK-1654 and placebo |
Biological: MK-1654
IM injection
Biological: Placebo
IM injection
|
| Active Comparator: Palivizumab Participants will receive IM injections. |
Biological: Palivizumab
IM injection
|
Outcome Measures
Primary Outcome Measures
- Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1 [Up to 5 days]
Percentage of participants with solicited injection-site AEs in RSV Season 1
- Participants with solicited daily body temperature with fever in RSV Season 1 [Up to 5 days]
Percentage of participants with solicited daily body temperature with fever in RSV Season 1
- Participants with solicited systemic AEs in RSV Season 1 [Up to 5 days]
Percentage of participants with solicited systemic AEs in RSV Season 1
- Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1 [Up to 42 days]
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
- Participants with rash AESI in RSV Season 1 [Up to 42 days]
Percentage of participants with rash AESI in RSV Season 1
- Participants with non-serious AEs in RSV Season 1 [Up to 42 days]
Percentage of participants with non-serious AEs in RSV Season 1
- Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 [Up to 365 days]
Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Secondary Outcome Measures
- Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 [Up to 150 days]
Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
- Participants with RSV-associated hospitalization in RSV Season 1 [Up to 150 days]
Percentage of participants with RSV-associated hospitalization in RSV Season 1
- Participants with solicited injection-site AEs in RSV Season 2 [From approximately 393 days up to 400 days]
Percentage of participants with solicited injection-site AEs in RSV Season 2
- Participants with solicited daily body temperature with fever in RSV Season 2 [From approximately 393 days up to 400 days]
Percentage of participants with solicited daily body temperature with fever in RSV Season 2
- Participants with solicited systemic AEs in RSV Season 2 [From approximately 393 days up to 400 days]
Percentage of participants with solicited systemic AEs in RSV Season 2
- Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 [From approximately 393 days up to 440 days]
Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
- Participants with rash AESI in RSV Season 2 [From approximately 393 days up to 440 days]
Percentage of participants with rash AESI in RSV Season 2
- Participants with non-serious AEs in RSV Season 2 [From approximately 393 days up to 440 days]
Percentage of participants with non-serious AEs in RSV Season 2
- Participants with SAEs in RSV Season 2 [From approximately 393 days up to 575 days]
Percentage of participants with SAEs in RSV Season 2
- Concentration of MK-1654 in RSV Season 1 [Up to 240 days]
Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 1
- Concentration of MK-1654 in RSV Season 2 [From approximately 393 days up to 550 days]
Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 2
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 1 Year
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
-
Is available to complete the follow-up period.
Exclusion Criteria:
-
Requires mechanical ventilation at time of enrollment.
-
Has a life expectancy <6 months.
-
Has known hepatic or renal dysfunction, or chronic seizure disorder.
-
Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
-
Has severe immunodeficiency or is severely immunocompromised.
-
Has known hypersensitivity to any component of MK-1654 or palivizumab.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M | Orlando | Florida | United States | 32806 |
| 2 | University of Kentucky HealthCare - Turfland ( Site 0044) | Lexington | Kentucky | United States | 40504 |
| 3 | University of Rochester Medical Center ( Site 0017) | Rochester | New York | United States | 14642 |
| 4 | The University of North Carolina at Chapel Hill ( Site 0035) | Chapel Hill | North Carolina | United States | 27514 |
| 5 | Tribe Clinical Research, LLC ( Site 0002) | Greenville | South Carolina | United States | 29607 |
| 6 | Driscoll Children's Hospital ( Site 0025) | Corpus Christi | Texas | United States | 78411 |
| 7 | DHR Health Institute for Research and Development ( Site 0029) | Edinburg | Texas | United States | 78504 |
| 8 | University Hospital-Pediatrics ( Site 0019) | San Antonio | Texas | United States | 78229 |
| 9 | Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004) | Spokane | Washington | United States | 99202 |
| 10 | MultiCare Health System-Baker Center ( Site 0036) | Tacoma | Washington | United States | 98405 |
| 11 | Telethon Kids Institute-Vaccine Trials Group ( Site 0101) | Nedlands | Western Australia | Australia | 6009 |
| 12 | Clínica Alemana de Santiago-Neonatology department ( Site 0207) | Santiago | Region M. De Santiago | Chile | 8320325 |
| 13 | Hospital Roberto del Río-Infectología Pediátrica ( Site 0205) | Santiago | Region M. De Santiago | Chile | 8380418 |
| 14 | Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201) | Santiago | Region M. De Santiago | Chile | 8880465 |
| 15 | Fundación Hospitalaria San Vicente de Paúl ( Site 0233) | Medellin | Antioquia | Colombia | 050010 |
| 16 | Clínica Universitaria Bolivariana ( Site 0227) | Medellin | Antioquia | Colombia | 50036 |
| 17 | Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230) | Bogota | Cundinamarca | Colombia | 1100100 |
| 18 | Instituto de investigaciones Centro Medico Imbanaco ( Site 0229) | Cali | Valle Del Cauca | Colombia | |
| 19 | MeVac - Meilahti Vaccine Research Center ( Site 0306) | Helsinki | Uusimaa | Finland | 00290 |
| 20 | Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332) | Bordeaux | Aquitaine | France | 33076 |
| 21 | Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq | Caen | Calvados | France | 14033 |
| 22 | Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331) | Le Chesnay | Yvelines | France | 78157 |
| 23 | Dr. von Haunersches Kinderspital ( Site 0358) | Munich | Bayern | Germany | 80337 |
| 24 | München Klinik Harlaching ( Site 0351) | Munich | Bayern | Germany | 81545 |
| 25 | Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359) | Oberhausen | Nordrhein-Westfalen | Germany | 46145 |
| 26 | Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin | Dresden | Sachsen | Germany | 01307 |
| 27 | Universitätsklinikum Leipzig-Neonatology ( Site 0354) | Leipzig | Sachsen | Germany | 04103 |
| 28 | ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855) | Chaidari | Attiki | Greece | 124 62 |
| 29 | Hippokration University Hopsital-3rd Pediatric Department ( Site 0851) | Thessaloniki | Kentriki Makedonia | Greece | 5 46 42 |
| 30 | Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380) | Kecskemét | Bacs-Kiskun | Hungary | 6000 |
| 31 | Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si | Miskolc | Borsod-Abauj-Zemplen | Hungary | 3526 |
| 32 | Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376) | Nyiregyhaza | Szabolcs-Szatmar-Bereg | Hungary | 4400 |
| 33 | Debreceni Egyetem Klinikai Kozpont ( Site 0378) | Debrecen | Hungary | 4032 | |
| 34 | Fukuoka Children's Hospital ( Site 0452) | Fukuoka-shi | Fukuoka | Japan | 813-0017 |
| 35 | Aso Iizuka Hospital ( Site 0457) | Iizuka | Fukuoka | Japan | 820-8505 |
| 36 | Japan Community Healthcare Organization Kyushu Hospital ( Site 0454) | Kitakyushu-shi | Fukuoka | Japan | 806-8501 |
| 37 | Maebashi Red Cross Hospital ( Site 0451) | Maebashi | Gunma | Japan | 371-0811 |
| 38 | Ibaraki Children's Hospital ( Site 0458) | Mito | Ibaraki | Japan | |
| 39 | Nihon University Itabashi Hospital ( Site 0453) | Itabashiku | Tokyo | Japan | 173-8610 |
| 40 | Shizuoka Saiseikai General Hospital ( Site 0456) | Shizuoka | Japan | 422-8527 | |
| 41 | National Center for Child Health and Development ( Site 0455) | Tokyo | Japan | 157-8535 | |
| 42 | Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477) | Kota Bharu | Kelantan | Malaysia | 15586 |
| 43 | Hospital Pulau Pinang ( Site 0482) | George Town | Pulau Pinang | Malaysia | 10990 |
| 44 | Sabah Women and Children Hospital ( Site 0478) | Kota Kinabalu | Sabah | Malaysia | 88996 |
| 45 | Hospital Sibu ( Site 0476) | Sibu | Sarawak | Malaysia | 96000 |
| 46 | Hospital Tunku Azizah-Paediatric ( Site 0481) | Kuala Lumpur | Malaysia | 50300 | |
| 47 | Instituto Nacional de Pediatria ( Site 0506) | Mexico City | Distrito Federal | Mexico | 04530 |
| 48 | Morales Vargas Centro de Investigacion ( Site 0509) | León | Guanajuato | Mexico | 37000 |
| 49 | Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508) | Durango | Mexico | 34000 | |
| 50 | Oaxaca Site Management Organization ( Site 0504) | Oaxaca | Mexico | 68000 | |
| 51 | ONCOLOGICO POTOSINO, S.C. ( Site 0505) | San Luis Potosi | Mexico | 78209 | |
| 52 | Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527) | Newtown | Wellington | New Zealand | 6021 |
| 53 | Middlemore Clinical Trials ( Site 0526) | Auckland | New Zealand | 2025 | |
| 54 | Oslo Universitetssykehus Ullevål ( Site 0551) | Oslo | Norway | 0450 | |
| 55 | UPR Medical Sciences Campus-Pediatrics ( Site 0626) | San Juan | Puerto Rico | 00935 | |
| 56 | Reimed ( Site 0706) | Boksburg | Gauteng | South Africa | 1459 |
| 57 | Chris Hani Baragwanath Academic Hospital ( Site 0701) | Soweto | Gauteng | South Africa | 2013 |
| 58 | King Edward VIII Hospital ( Site 0704) | Durban | Kwazulu-Natal | South Africa | 4001 |
| 59 | Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703) | Cape Town | Western Cape | South Africa | 7500 |
| 60 | Panorama Medical Centre ( Site 0702) | Cape Town | Western Cape | South Africa | 7500 |
| 61 | 2 Military Hospital ( Site 0708) | Cape Town | Western Cape | South Africa | 7824 |
| 62 | Hospital Universitario Central de Asturias ( Site 0740) | Oviedo | Asturias | Spain | 33011 |
| 63 | Hospital Germans Trias i Pujol ( Site 0738) | Badalona | Barcelona | Spain | 08916 |
| 64 | Hospital Sant Joan de Déu ( Site 0730) | Esplugues de Llobregat | Barcelona | Spain | 08950 |
| 65 | Hospital Universitary General de Catalunya-Pediatrics ( Site 0737) | Sant Cugat del Vallès | Barcelona | Spain | 08195 |
| 66 | CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731) | Santiago de Compostela | La Coruna | Spain | 15706 |
| 67 | Hospital Universitario La Paz ( Site 0726) | Madrid | Madrid, Comunidad De | Spain | 28046 |
| 68 | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739) | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 69 | Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07 | Madrid | Spain | 28041 | |
| 70 | Grupo Pediatrico Uncibay ( Site 0734) | Malaga | Spain | 29015 | |
| 71 | Taichung Veterans General Hospital ( Site 0754) | Taichung | Taiwan | 407 | |
| 72 | National Taiwan University Hospital ( Site 0751) | Taipei | Taiwan | 10002 | |
| 73 | Mackay Memorial Hospital-Pediatrics ( Site 0753) | Taipei | Taiwan | ||
| 74 | Chang Gung Medical Foundation-Linkou Branch ( Site 0752) | Taoyuan | Taiwan | 333 | |
| 75 | Ankara University Hospital Cebeci ( Site 0801) | Ankara | Turkey | 06100 | |
| 76 | Gazi Universitesi ( Site 0806) | Ankara | Turkey | 06560 | |
| 77 | Southampton General Hospital ( Site 0826) | Southampton | Hampshire | United Kingdom | SO16 0YD |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT04938830
Other Study ID Numbers:
- 1654-007
- MK-1654-007
- jRCT2031210664
- 2020-005996-11
First Posted:
Jun 24, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: