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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04938830




Registration number
NCT04938830
Ethics application status
Date submitted
22/06/2021
Date registered
24/06/2021

Titles & IDs
Public title
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Scientific 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
Secondary ID [1] 0 0
MK-1654-007
Secondary ID [2] 0 0
1654-007
Universal Trial Number (UTN)
Trial acronym
SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Clesrovimab
Treatment: Other - Palivizumab
Treatment: Other - Placebo

Experimental: Clesrovimab - Participants will receive intramuscular (IM) injections of clesrovimab and placebo

Active comparator: Palivizumab - Participants will receive IM injections.


Treatment: Other: Clesrovimab
IM injection

Treatment: Other: Palivizumab
IM injection

Treatment: Other: Placebo
IM injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
Timepoint [1] 0 0
Up to 5 days
Primary outcome [2] 0 0
Participants with solicited daily body temperature with fever in RSV Season 1
Timepoint [2] 0 0
Up to 5 days
Primary outcome [3] 0 0
Participants with solicited systemic AEs in RSV Season 1
Timepoint [3] 0 0
Up to 5 days
Primary outcome [4] 0 0
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Timepoint [4] 0 0
Up to 42 days
Primary outcome [5] 0 0
Participants with rash AESI in RSV Season 1
Timepoint [5] 0 0
Up to 42 days
Primary outcome [6] 0 0
Participants with non-serious AEs in RSV Season 1
Timepoint [6] 0 0
Up to 42 days
Primary outcome [7] 0 0
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Timepoint [7] 0 0
Up to 365 days
Secondary outcome [1] 0 0
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Timepoint [1] 0 0
Up to 150 days
Secondary outcome [2] 0 0
Participants with RSV-associated hospitalization in RSV Season 1
Timepoint [2] 0 0
Up to 150 days
Secondary outcome [3] 0 0
Participants with solicited injection-site AEs in RSV Season 2
Timepoint [3] 0 0
From approximately 393 days up to 400 days
Secondary outcome [4] 0 0
Participants with solicited daily body temperature with fever in RSV Season 2
Timepoint [4] 0 0
From approximately 393 days up to 400 days
Secondary outcome [5] 0 0
Participants with solicited systemic AEs in RSV Season 2
Timepoint [5] 0 0
From approximately 393 days up to 400 days
Secondary outcome [6] 0 0
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Timepoint [6] 0 0
From approximately 393 days up to 440 days
Secondary outcome [7] 0 0
Participants with rash AESI in RSV Season 2
Timepoint [7] 0 0
From approximately 393 days up to 440 days
Secondary outcome [8] 0 0
Participants with non-serious AEs in RSV Season 2
Timepoint [8] 0 0
From approximately 393 days up to 440 days
Secondary outcome [9] 0 0
Participants with SAEs in RSV Season 2
Timepoint [9] 0 0
From approximately 393 days up to 575 days
Secondary outcome [10] 0 0
Concentration of clesrovimab in RSV Season 1
Timepoint [10] 0 0
Up to 240 days
Secondary outcome [11] 0 0
Concentration of clesrovimab in RSV Season 2
Timepoint [11] 0 0
From approximately 393 days up to 550 days

Eligibility
Key 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.
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 clesrovimab or palivizumab.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Mater Misericordiae Limited-Neonatalogy ( Site 0102) - Brisbane
Recruitment hospital [2] 0 0
Telethon Kids Institute-Vaccine Trials Group ( Site 0101) - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Idaho
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Canada
State/province [18] 0 0
Alberta
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Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
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Quebec
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Chile
State/province [21] 0 0
Region M. De Santiago
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Distrito Capital De Bogota
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Colombia
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Valle Del Cauca
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Czechia
State/province [26] 0 0
Moravskoslezsky Kraj
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Czechia
State/province [27] 0 0
Praha 4
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Finland
State/province [28] 0 0
Mellersta Osterbotten
Country [29] 0 0
Finland
State/province [29] 0 0
Pirkanmaa
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Finland
State/province [30] 0 0
Pohjois-Pohjanmaa
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Finland
State/province [31] 0 0
Sodra Osterbotten
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Finland
State/province [32] 0 0
Uusimaa
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Finland
State/province [33] 0 0
Varsinais-Suomi
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France
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Aquitaine
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France
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Calvados
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France
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Yvelines
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
State/province [41] 0 0
Sachsen
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Germany
State/province [42] 0 0
Schleswig-Holstein
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Greece
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Attiki
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Greece
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Kentriki Makedonia
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Hong Kong
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Shatin
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Hong Kong
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Tuen Mun
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Hungary
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Bacs-Kiskun
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Szabolcs-Szatmar-Bereg
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Hungary
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Budapest
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Hungary
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Debrecen
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Lazio
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Lombardia
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Italy
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Veneto
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Italy
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Parma
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Fukuoka
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Japan
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Gunma
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Japan
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Ibaraki
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Japan
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Tokyo
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Japan
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Shizuoka
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Sabah
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Sarawak
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Distrito Federal
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Guanajuato
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Jalisco
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Durango
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Oaxaca
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Mexico
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San Luis Potosi
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New Zealand
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Wellington
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Auckland
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Norway
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Oslo
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Peru
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Lima
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Puerto Rico
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San Juan
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Singapore
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South West
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Malaga
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
State/province [89] 0 0
Krung Thep Maha Nakhon
Country [90] 0 0
Thailand
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Songkhla
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Kayseri
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United Kingdom
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England
Country [95] 0 0
United Kingdom
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Glasgow City
Country [96] 0 0
United Kingdom
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Great Britain
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United Kingdom
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Hampshire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London, City Of
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Oxfordshire
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04938830