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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)
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)
Secondary ID [1] 0 0
2019-000114-11
Secondary ID [2] 0 0
D5290C00004
Universal Trial Number (UTN)
Trial acronym
MELODY
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Timepoint [1] 0 0
Through 150 Days Post Dose
Secondary outcome [1] 0 0
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Timepoint [1] 0 0
Through 150 Days Post Dose
Secondary outcome [2] 0 0
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Timepoint [2] 0 0
By visit until day 360 post dose
Secondary outcome [3] 0 0
Anti-drug Antibody Results by Visit (As Treated Population)
Timepoint [3] 0 0
From baseline to 360 day post dose visit

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
Minimum age
0 Years
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2023
Sample size
Target
Accrual to date
Final
3012
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Mississippi
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Missouri
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Wisconsin
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Argentina
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San Miguel de Tucuman
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Graz
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Brugge
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Gent
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Sofia
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Chia
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Paide
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Turku
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Incheon
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Chorrera
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Spain
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Valencia
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Sweden
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Linköping
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Sweden
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Stockholm
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Turkey
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Adana
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Ankara
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Izmir
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Turkey
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Kocaeli
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Ukraine
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Chernivts?
Country [143] 0 0
Ukraine
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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

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03979313