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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 (MELODY)

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ClinicalTrials.gov Identifier: NCT03979313
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE July 23, 2019
Actual Primary Completion Date March 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
Incidence of medically attended LRTI due to RT-PCR confirmed RSV [ Time Frame: 150 days post dose ]
The incidence of RSV LRTI (inpatient and outpatient) 150 days post dose will be based on RSV test results (performed centrally via RT-PCR) and objective clinical LRTI criteria and will be presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV LRTI will be estimated from model.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV [ Time Frame: 150 days post dose ]
    The incidence of RSV hospitalization 150 days post dose will be presented by treatment group. The relative risk reduction of MEDI8897 over placebo in preventing RSV hospitalization will be estimated from model.
  • Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) [ Time Frame: 360 days post dose ]
    Safety of MEDI8897 will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs. Other safety assessments will include the occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).
  • Single-dose serum concentrations of MEDI8897 [ Time Frame: 360 days post dose ]
    MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group.
  • Incidence of anti-drug antibody (ADA) to MEDI8897 in serum [ Time Frame: 360 days post dose ]
    The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Syncytial Virus Infections
Intervention  ICMJE
  • Drug: MEDI8897
    Anti-RSV monoclonal antibody with an extended half-life
  • Drug: Placebo
    Commercially available 0.9% (w/v) saline
Study Arms  ICMJE
  • Experimental: MEDI8897
    Anti-RSV monoclonal antibody with an extended half-life
    Intervention: Drug: MEDI8897
  • Placebo Comparator: Placebo
    Commercially available 0.9% (w/v) saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 29, 2023
Actual Primary Completion Date March 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czechia,   Estonia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   New Zealand,   Panama,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT03979313
Other Study ID Numbers  ICMJE D5290C00004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP