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
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Condition or disease | Intervention/treatment | Phase |
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Respiratory Syncytial Virus Infections | Drug: MEDI8897 Drug: Placebo | Phase 3 |
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 |
Arm | Intervention/treatment |
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Experimental: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
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Drug: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life |
Placebo Comparator: Placebo
Commercially available 0.9% (w/v) saline
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Drug: Placebo
Commercially available 0.9% (w/v) saline |
- 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)
- 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)
- 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
- 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
- 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)
- 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)
- Number of Participants With Disease From the 2nd RSV Season (All Subjects) [ Time Frame: From Day 361 to Day 510 Post Dose ]
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.
Ages Eligible for Study: | 0 Years to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Documents provided by AstraZeneca:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Respiratory Syncytial Virus RSV Late Preterm Infants Healthy Infants Lower Respiratory Tract Infection |
Infections Respiratory Tract Infections Respiratory Syncytial Virus Infections Virus Diseases Respiratory Tract Diseases |
Pneumovirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |