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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05238974




Registration number
NCT05238974
Ethics application status
Date submitted
4/02/2022
Date registered
14/02/2022
Date last updated
14/02/2022

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants
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
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
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: 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
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Timepoint [1] 0 0
150 days post dose
Secondary outcome [1] 0 0
Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV
Timepoint [1] 0 0
150 days post dose
Secondary outcome [2] 0 0
Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE)
Timepoint [2] 0 0
360 days post dose
Secondary outcome [3] 0 0
Single-dose serum concentrations of MEDI8897
Timepoint [3] 0 0
360 days post dose
Secondary outcome [4] 0 0
Incidence of anti-drug antibody (ADA) to MEDI8897 in serum
Timepoint [4] 0 0
360 days post dose

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
No limit
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
Active, not recruiting
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
23/03/2023
Actual
Sample size
Target
Accrual to date
Final
2965
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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT05238974
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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