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Monoclonal Antibodies

MEDI8897 for Respiratory Syncytial Virus (MELODY Trial)

Phase 3
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 361 to day 510 post dose
Awards & highlights

MELODY Trial Summary

This trial will test how well a new RSV drug works in late-term and full-term infants during their first RSV season.

Eligible Conditions
  • Respiratory Syncytial Virus (RSV)
  • Respiratory Syncytial Virus

MELODY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 361 to day 510 post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 361 to day 510 post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Secondary outcome measures
Anti-drug Antibody Results by Visit (As Treated Population)
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Other outcome measures
Number of Participants With Disease From the 2nd RSV Season (All Subjects)
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)

Side effects data

From 2023 Phase 2 & 3 trial • 925 Patients • NCT03959488
21%
Upper respiratory tract infection
21%
Nasopharyngitis
17%
Diarrhoea
14%
Pyrexia
14%
Rhinitis
12%
Covid-19
7%
Vomiting
7%
Conjunctivitis
5%
Constipation
5%
Gastroenteritis
5%
Otitis media acute
5%
Roseola
5%
Speech disorder developmental
5%
Vaccination complication
5%
Rhinorrhoea
5%
Otitis media
5%
Ear infection
5%
Viral upper respiratory tract infection
5%
Hand-foot-and-mouth disease
5%
Sars-cov-2 test positive
5%
Bronchiolitis
5%
Teething
2%
Phimosis
2%
Tympanic membrane perforation
2%
Dry skin
2%
Food allergy
2%
Enterovirus infection
2%
Dermatitis contact
2%
Rash
2%
Otitis media chronic
2%
Flatulence
2%
Adenovirus infection
2%
Abdominal pain
2%
Pneumonia
2%
Hypothyroidism
2%
Adenoiditis
2%
Rhinitis allergic
2%
Tonsillar hypertrophy
2%
Dermatitis diaper
2%
Skin irritation
2%
Bronchitis
2%
Tracheitis
2%
Lice infestation
2%
Lower respiratory tract infection viral
2%
Enteritis
2%
Molluscum contagiosum
2%
Tonsillitis
2%
Otitis externa
2%
Rotavirus infection
2%
Dermatitis atopic
2%
Tongue injury
2%
Laryngitis
2%
Feeding disorder
2%
Sars-cov-2 test negative
2%
Eczema
2%
Nasal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palivizumab/Palivizumab
MEDI8897
MEDI8897/MEDI8897
Palivizumab
Palivizumab/MEDI8897

MELODY Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MEDI8897Experimental Treatment1 Intervention
Anti-RSV monoclonal antibody with an extended half-life
Group II: PlaceboPlacebo Group1 Intervention
Commercially available 0.9% (w/v) saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI8897
2016
Completed Phase 3
~5390

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
790,897 Total Patients Enrolled
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,603,969 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include middle-aged individuals as participants?

"Our team is currently enrolling infants that are less than one year old."

Answered by AI

Which type of patient is this clinical trial meant for?

"The target population for this clinical trial are infants aged 0-1 year old that have respiratory syncytial virus infections. Additionally, participants must be born 35 weeks or later and be general healthy."

Answered by AI

Is this a new treatment protocol?

"MEDI8897's clinical trials began in 2019 with AstraZeneca sponsoring the first study of 3013 people. After the success of the first Phase 3 trial, there are currently 4 active trials in 108 cities and 34 countries."

Answered by AI

Has MEDI8897 been cleared by the FDA?

"MEDI8897 safety is estimated to be a 3. This is due to the fact that this is a Phase 3 trial, where there is already some data to suggest the efficacy of the MEDI8897 as well as multiple rounds of data affirming its safety."

Answered by AI

What other MEDI8897 research is available?

"There are three Phase 3 trials and one additional study currently underway for MEDI8897. The majority of these studies are being conducted in Plovdiv, with additional research taking place in North carolina. In total, there are 490 clinical trial sites for MEDI8897."

Answered by AI

Could you please enumerate how many hospitals are trialing this new procedure?

"There are 78 hospitals participating in this study, with a few being located in Tacoma, Charleston and Pittsburgh. If you are interested in enrolling, it might be simplest to choose the closest location to reduce travel."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
< 18
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
The Lancet Global HealthJournal
Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia
Ginsburg, Amy Sarah, and Padmini Srikantiah. 2021. “Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia”. The Lancet Global Health. Elsevier BV. doi:10.1016/s2214-109x(21)00455-1.
New England Journal of MedicineJournal
Nirsevimab for Prevention of RSV in Healthy Late-preterm and Term Infants
Hammitt, Laura L., Ron Dagan, Yuan Yuan, Manuel Baca Cots, Miroslava Bosheva, Shabir A. Madhi, William J. Muller, et al.. 2022. “Nirsevimab for Prevention of RSV in Healthy Late-preterm and Term Infants”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2110275.
clinicaltrials.govStudy
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)
2019. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03979313.
~532 spots leftby Apr 2025
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