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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
Date last updated
12/11/2024

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
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
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United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Florida
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United States of America
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Georgia
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United States of America
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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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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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South Carolina
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Texas
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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
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Moravskoslezsky Kraj
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Czechia
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Praha 4
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Finland
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Mellersta Osterbotten
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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
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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
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Sachsen
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Germany
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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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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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Debrecen
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Lazio
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Lombardia
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Veneto
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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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Malaysia
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Sabah
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Malaysia
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Sarawak
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Distrito Federal
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Guanajuato
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Mexico
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Jalisco
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Durango
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Mexico
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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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South Africa
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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
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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
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United Kingdom
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Glasgow City
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United Kingdom
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Great Britain
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United Kingdom
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Hampshire
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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
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
Trial website
https://clinicaltrials.gov/study/NCT04938830
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04938830