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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03979313
Registration number
NCT03979313
Ethics application status
Date submitted
30/05/2019
Date registered
7/06/2019
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
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Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
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Secondary ID [1]
0
0
2019-000114-11
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Secondary ID [2]
0
0
D5290C00004
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Universal Trial Number (UTN)
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Trial acronym
MELODY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MEDI8897
Treatment: Drugs - Placebo
Experimental: MEDI8897 - Anti-RSV monoclonal antibody with an extended half-life
Placebo comparator: Placebo - Commercially available 0.9% (w/v) saline
Treatment: Drugs: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Treatment: Drugs: Placebo
Commercially available 0.9% (w/v) saline
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
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Assessment method [1]
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Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
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Timepoint [1]
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Through 150 Days Post Dose
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Secondary outcome [1]
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Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
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Assessment method [1]
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Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
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Timepoint [1]
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Through 150 Days Post Dose
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Secondary outcome [2]
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Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
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Assessment method [2]
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Number of Subjects with at Least one Assessment
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Timepoint [2]
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By visit until day 360 post dose
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Secondary outcome [3]
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Anti-drug Antibody Results by Visit (As Treated Population)
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Assessment method [3]
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Number of subjects with a positive result and a valid titer result at the specific visit
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Timepoint [3]
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From baseline to 360 day post dose visit
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Eligibility
Key inclusion criteria
Key
* Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
* Infants who are entering their first RSV season at the time of screening
Key
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Minimum age
0
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Maximum age
1
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Meets national or other local criteria to receive commercial palivizumab
* Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/03/2023
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Sample size
Target
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Accrual to date
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Final
3012
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Recruitment hospital [2]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Izmir
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Turkey
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Kocaeli
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Ukraine
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State/province [142]
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Chernivts?
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Country [143]
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Ukraine
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State/province [143]
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Dnipro
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Ukraine
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Kyiv
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Ukraine
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Sumy
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Ukraine
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Vinnytsia
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United Kingdom
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Liverpool
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
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Trial website
https://clinicaltrials.gov/study/NCT03979313
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Trial related presentations / publications
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275. 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.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/13/NCT03979313/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT03979313/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03979313