The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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) (MELODY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979313
Recruitment Status : Completed
First Posted : June 7, 2019
Results First Posted : February 28, 2024
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: MEDI8897 Drug: Placebo Phase 3

Detailed Description:
This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : March 11, 2021
Actual Study Completion Date : March 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
 Drug: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Placebo Comparator: Placebo
Commercially available 0.9% (w/v) saline
 Drug: Placebo
Commercially available 0.9% (w/v) saline


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) [ Time Frame: Through 150 Days Post Dose ]
    Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)


Secondary Outcome Measures :
  1. Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) [ Time Frame: Through 150 Days Post Dose ]
    Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)

  2. Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group [ Time Frame: By visit until day 360 post dose ]
    Number of Subjects with at Least one Assessment

  3. Anti-drug Antibody Results by Visit (As Treated Population) [ Time Frame: From baseline to 360 day post dose visit ]
    Number of subjects with a positive result and a valid titer result at the specific visit


Other Outcome Measures:
  1. Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects) [ Time Frame: Through 150 Days Post Dose ]
    Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants)

  2. Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects) [ Time Frame: Through 150 Days Post Dose ]
    Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants)

  3. Number of Participants With Disease From the 2nd RSV Season (All Subjects) [ Time Frame: From Day 361 to Day 510 Post Dose ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   0 Years to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979313


Locations
Show Show 199 study locations
Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] February 1, 2021
Statistical Analysis Plan  [PDF] April 11, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03979313    
Obsolete Identifiers: NCT05238974
Other Study ID Numbers: D5290C00004
2019-000114-11 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Results First Posted: February 28, 2024
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 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.
Access Criteria: 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Respiratory Syncytial Virus
RSV
Late Preterm Infants
Healthy Infants
Lower Respiratory Tract Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Virus Diseases
Respiratory Tract Diseases
 Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections