Back to resultsA 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)
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MEDI8897
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus, RSV, Late Preterm Infants, Healthy Infants, Lower Respiratory Tract Infection
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MEDI8897
Placebo
Arm Description
Anti-RSV monoclonal antibody with an extended half-life
Commercially available 0.9% (w/v) saline
Outcomes
Primary Outcome Measures
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
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.
Secondary Outcome Measures
Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV
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)
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
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
The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03979313
Brief Title
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)
Acronym
MELODY
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory Syncytial Virus, RSV, Late Preterm Infants, Healthy Infants, Lower Respiratory Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3012 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI8897
Arm Type
Experimental
Arm Description
Anti-RSV monoclonal antibody with an extended half-life
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Commercially available 0.9% (w/v) saline
Intervention Type
Drug
Intervention Name(s)
MEDI8897
Intervention Description
Anti-RSV monoclonal antibody with an extended half-life
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Commercially available 0.9% (w/v) saline
Primary Outcome Measure Information:
Title
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Description
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.
Time Frame
150 days post dose
Secondary Outcome Measure Information:
Title
Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed RSV
Description
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.
Time Frame
150 days post dose
Title
Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE)
Description
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).
Time Frame
360 days post dose
Title
Single-dose serum concentrations of MEDI8897
Description
MEDI8897 serum concentration levels will be assessed by mean serum concentration of MEDI8897 at pre-specified timepoints and tabulated by treatment group.
Time Frame
360 days post dose
Title
Incidence of anti-drug antibody (ADA) to MEDI8897 in serum
Description
The incidence of ADA to MEDI8897 will be assessed and summarized by percentage of subjects that are ADA positive by treatment group.
Time Frame
360 days post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
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Research Site
City
Fort Defiance
State/Province
Arizona
ZIP/Postal Code
86504
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United States
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Research Site
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Fayetteville
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Arkansas
ZIP/Postal Code
72703
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United States
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Research Site
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Anaheim
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California
ZIP/Postal Code
92804
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United States
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Research Site
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Downey
State/Province
California
ZIP/Postal Code
90240
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United States
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Research Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
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Research Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
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United States
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Research Site
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West Covina
State/Province
California
ZIP/Postal Code
91790
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United States
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Research Site
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Aurora
State/Province
Colorado
ZIP/Postal Code
80015
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United States
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Research Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
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United States
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Research Site
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Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
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United States
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Gainesville
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Florida
ZIP/Postal Code
32653
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United States
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Hialeah
State/Province
Florida
ZIP/Postal Code
33012
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United States
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Miami
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Florida
ZIP/Postal Code
33142
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United States
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Atlanta
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Georgia
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30322
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United States
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Fort Gordon
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Georgia
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30905
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United States
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Chicago
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Illinois
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60611
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United States
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Oak Lawn
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Illinois
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60453
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Indianapolis
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Indiana
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46202
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West Des Moines
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Iowa
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50266
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Bardstown
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Kentucky
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40004
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United States
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Lexington
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Kentucky
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40517
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United States
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Shreveport
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Louisiana
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71105
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United States
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Jackson
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Mississippi
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39216
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United States
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Columbia
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Missouri
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65212
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United States
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Lincoln
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Nebraska
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68504
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United States
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Omaha
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Nebraska
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68114
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United States
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Gallup
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New Mexico
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87301
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United States
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Shiprock
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New Mexico
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87420
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United States
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Syracuse
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New York
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13210
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United States
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Boone
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North Carolina
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28607
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United States
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Cincinnati
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Ohio
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45229
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United States
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Cleveland
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Ohio
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44109
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United States
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Cleveland
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Ohio
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44121
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United States
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Columbus
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Ohio
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43205
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United States
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Dayton
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Ohio
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45406
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United States
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City
Dayton
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Ohio
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45414
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United States
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Oklahoma City
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Oklahoma
ZIP/Postal Code
73104
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United States
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Erie
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Pennsylvania
ZIP/Postal Code
16506
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United States
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Pittsburgh
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Pennsylvania
ZIP/Postal Code
15213
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United States
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Warwick
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Rhode Island
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02886
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United States
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North Charleston
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South Carolina
ZIP/Postal Code
29406
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United States
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Sioux Falls
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South Dakota
ZIP/Postal Code
57105
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United States
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Kingsport
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Tennessee
ZIP/Postal Code
37660
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United States
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Memphis
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Tennessee
ZIP/Postal Code
38103
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United States
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Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
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United States
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Baytown
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Texas
ZIP/Postal Code
77521
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United States
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Dallas
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Texas
ZIP/Postal Code
75251
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United States
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Edinburg
State/Province
Texas
ZIP/Postal Code
78539
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United States
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League City
State/Province
Texas
ZIP/Postal Code
77573
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United States
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Longview
State/Province
Texas
ZIP/Postal Code
75605
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United States
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Pearland
State/Province
Texas
ZIP/Postal Code
77584
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United States
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City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
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Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
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Research Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
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Research Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
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Research Site
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
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Research Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
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Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
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Research Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
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Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Research Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
T4000NWB
Country
Argentina
Facility Name
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City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
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City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
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City
Graz
ZIP/Postal Code
8036
Country
Austria
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City
Vienna
ZIP/Postal Code
1090
Country
Austria
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City
Brugge
ZIP/Postal Code
8000
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Belgium
Facility Name
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City
Brussels
ZIP/Postal Code
1070
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Belgium
Facility Name
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City
Brussels
ZIP/Postal Code
1090
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Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
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City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
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City
Pazardzhik
ZIP/Postal Code
4400
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Bulgaria
Facility Name
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City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
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Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
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Bulgaria
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
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City
Calgary
State/Province
Alberta
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T3B 6A8
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Canada
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City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
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Canada
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City
Pierrefonds
State/Province
Quebec
ZIP/Postal Code
H9H 4Y6
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Canada
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City
Santiago
ZIP/Postal Code
8880465
Country
Chile
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City
Cali
Country
Colombia
Facility Name
Research Site
City
Chia
ZIP/Postal Code
250002
Country
Colombia
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
50036
Country
Colombia
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
500515
Country
Colombia
Facility Name
Research Site
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Research Site
City
Soledad
ZIP/Postal Code
083001
Country
Colombia
Facility Name
Research Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czechia
Facility Name
Research Site
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Research Site
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Research Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Research Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Research Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Research Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Research Site
City
Seinäjoki
ZIP/Postal Code
60100
Country
Finland
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Research Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
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Research Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Research Site
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
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Research Site
City
Bordeaux
ZIP/Postal Code
33000
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France
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City
Brest
ZIP/Postal Code
29609
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France
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City
Bron
ZIP/Postal Code
69677
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France
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City
Caen
ZIP/Postal Code
14033
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France
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Creteil Cedex
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94010
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France
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City
Lille
ZIP/Postal Code
59020
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France
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City
Frankenthal
ZIP/Postal Code
67227
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Germany
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City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Research Site
City
Beer-Sheva
ZIP/Postal Code
84001
Country
Israel
Facility Name
Research Site
City
Netanya
ZIP/Postal Code
4244916
Country
Israel
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00137
Country
Italy
Facility Name
Research Site
City
Fukuyama-shi
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
210-0013
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-0811
Country
Japan
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
556-0005
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
062-0931
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
ZIP/Postal Code
420-0005
Country
Japan
Facility Name
Research Site
City
Yokosuka-shi
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Jekabpils
ZIP/Postal Code
LV-5201
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1004
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
4200
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Research Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Research Site
City
Chorrera
Country
Panama
Facility Name
Research Site
City
Cuidad De Panama
Country
Panama
Facility Name
Research Site
City
David
Country
Panama
Facility Name
Research Site
City
Panama City
Country
Panama
Facility Name
Research Site
City
Panama
Country
Panama
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-348
Country
Poland
Facility Name
Research Site
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Research Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
51-169
Country
Poland
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614066
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2112
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0101
Country
South Africa
Facility Name
Research Site
City
Rondebosch
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Research Site
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Antequera
ZIP/Postal Code
29200
Country
Spain
Facility Name
Research Site
City
Castellon de la Plana
ZIP/Postal Code
12004
Country
Spain
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Research Site
City
Leganes
ZIP/Postal Code
28911
Country
Spain
Facility Name
Research Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29004
Country
Spain
Facility Name
Research Site
City
Mostoles
ZIP/Postal Code
28938
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Research Site
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Research Site
City
Sant Cugat del Valles
ZIP/Postal Code
08190
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Linköping
ZIP/Postal Code
587 58
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Research Site
City
Chernivtsі
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Research Site
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21021
Country
Ukraine
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
35235726
Citation
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
Results Reference
derived
PubMed Identifier
34774184
Citation
Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
Results Reference
derived
Learn more about this trial
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)
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