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)

February 5, 2024 updated by: AstraZeneca

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3012

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Miguel de Tucuman, Argentina, 4000
        • Research Site
      • San Miguel de Tucuman, Argentina, T4000NWB
        • Research Site
  • Australia
      • Clayton, Australia, 3168
        • Research Site
      • Nedlands, Australia, 6009
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Vienna, Austria, 1090
        • Research Site
  • Belgium
      • Brugge, Belgium, 8000
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1070
        • Research Site
      • Bruxelles, Belgium, 1000
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
  • Bulgaria
      • Montana, Bulgaria, 3400
        • Research Site
      • Pazardzhik, Bulgaria, 4400
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Ruse, Bulgaria, 7002
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Research Site
    • Quebec
      • Pierrefonds, Quebec, Canada, H9H 4Y6
        • Research Site
  • Chile
      • Santiago, Chile, 8880465
        • Research Site
  • Colombia
      • Cali, Colombia
        • Research Site
      • Chia, Colombia, 250002
        • Research Site
      • Medellin, Colombia, 50036
        • Research Site
      • Medellin, Colombia, 500515
        • Research Site
      • Monteria, Colombia, 230002
        • Research Site
      • Soledad, Colombia, 083001
        • Research Site
  • Czechia
      • Havlickuv Brod, Czechia, 580 22
        • Research Site
  • Estonia
      • Paide, Estonia, 72713
        • Research Site
      • Tallinn, Estonia, 10617
        • Research Site
      • Tallinn, Estonia, 13419
        • Research Site
      • Tallinn, Estonia, 10117
        • Research Site
      • Tartu, Estonia, 50406
        • Research Site
  • Finland
      • Espoo, Finland, 02230
        • Research Site
      • Helsinki, Finland, 00100
        • Research Site
      • Jarvenpaa, Finland, 04400
        • Research Site
      • Kokkola, Finland, 67100
        • Research Site
      • Oulu, Finland, 90220
        • Research Site
      • Pori, Finland, 28100
        • Research Site
      • Seinäjoki, Finland, 60100
        • Research Site
      • Tampere, Finland, 33100
        • Research Site
      • Turku, Finland, 20520
        • Research Site
  • France
      • Amiens Cedex 1, France, 80054
        • Research Site
      • Bordeaux, France, 33000
        • Research Site
      • Brest, France, 29609
        • Research Site
      • Bron, France, 69677
        • Research Site
      • Caen, France, 14033
        • Research Site
      • Creteil Cedex, France, 94010
        • Research Site
      • Lille, France, 59020
        • Research Site
  • Germany
      • Frankenthal, Germany, 67227
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Mannheim, Germany, 68161
        • Research Site
  • Israel
      • Beer-Sheva, Israel, 84001
        • Research Site
      • Netanya, Israel, 4244916
        • Research Site
  • Italy
      • Roma, Italy, 00137
        • Research Site
  • Japan
      • Fukuyama-shi, Japan, 721-8511
        • Research Site
      • Kawasaki-shi, Japan, 210-0013
        • Research Site
      • Maebashi-shi, Japan, 371-0811
        • Research Site
      • Okayama-shi, Japan, 701-1192
        • Research Site
      • Osaka-shi, Japan, 556-0005
        • Research Site
      • Sapporo-shi, Japan, 062-0931
        • Research Site
      • Shizuoka-shi, Japan, 420-0005
        • Research Site
      • Yokosuka-shi, Japan, 238-8558
        • Research Site
  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
  • Latvia
      • Jekabpils, Latvia, LV-5201
        • Research Site
      • Riga, Latvia, 1004
        • Research Site
      • Riga, Latvia, LV1002
        • Research Site
      • Valmiera, Latvia, 4200
        • Research Site
      • Valmiera, Latvia, LV-4201
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 48259
        • Research Site
      • Kaunas, Lithuania, 50161
        • Research Site
  • Mexico
      • Mexico, Mexico, 06720
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
      • Grafton, New Zealand, 1023
        • Research Site
      • Papatoetoe, New Zealand, 2025
        • Research Site
      • Wellington, New Zealand, 6021
        • Research Site
  • Panama
      • Chorrera, Panama
        • Research Site
      • Cuidad De Panama, Panama
        • Research Site
      • David, Panama
        • Research Site
      • Panama, Panama
        • Research Site
      • Panama City, Panama
        • Research Site
  • Poland
      • Krakow, Poland, 30-363
        • Research Site
      • Kraków, Poland, 30-348
        • Research Site
      • Leczna, Poland, 21-010
        • Research Site
      • Toruń, Poland, 87-100
        • Research Site
      • Wroclaw, Poland, 53-149
        • Research Site
      • Wrocław, Poland, 51-169
        • Research Site
  • Russian Federation
      • Perm, Russian Federation, 614066
        • Research Site
      • Saint Petersburg, Russian Federation, 191025
        • Research Site
      • St Petersburg, Russian Federation, 193312
        • Research Site
      • St Petersburg, Russian Federation, 196084
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7505
        • Research Site
      • Cape Town, South Africa, 7800
        • Research Site
      • Cape Town, South Africa, 7530
        • Research Site
      • Durban, South Africa, 4091
        • Research Site
      • Johannesburg, South Africa, 2193
        • Research Site
      • Johannesburg, South Africa, 2112
        • Research Site
      • Pretoria, South Africa, 0101
        • Research Site
      • Pretoria, South Africa, 0087
        • Research Site
      • Rondebosch, South Africa, 7700
        • Research Site
      • Soweto, South Africa, 2013
        • Research Site
  • Spain
      • Alicante, Spain, 03010
        • Research Site
      • Antequera, Spain, 29200
        • Research Site
      • Castellon de la Plana, Spain, 12004
        • Research Site
      • Cordoba, Spain, 14004
        • Research Site
      • Granada, Spain, 18014
        • Research Site
      • La Laguna, Spain, 38320
        • Research Site
      • Leganes, Spain, 28911
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Malaga, Spain, 29004
        • Research Site
      • Mostoles, Spain, 28938
        • Research Site
      • Pozuelo de Alarcon, Spain, 28223
        • Research Site
      • San Juan de Alicante, Spain, 03550
        • Research Site
      • Sant Cugat del Valles, Spain, 08190
        • Research Site
      • Santiago de Compostela, Spain, 15706
        • Research Site
      • Valencia, Spain, 46017
        • Research Site
  • Sweden
      • Linköping, Sweden, 587 58
        • Research Site
      • Stockholm, Sweden, 118 83
        • Research Site
  • Turkey
      • Adana, Turkey, 01330
        • Research Site
      • Ankara, Turkey, 06100
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58001
        • Research Site
      • Dnipro, Ukraine, 49027
        • Research Site
      • Kyiv, Ukraine, 04050
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site
      • Vinnytsia, Ukraine, 21021
        • Research Site
  • United Kingdom
      • Liverpool, United Kingdom, L12 2AP
        • Research Site
      • London, United Kingdom, SW17 0RE
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Research Site
    • Arizona
      • Fort Defiance, Arizona, United States, 86504
        • Research Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Research Site
    • California
      • Anaheim, California, United States, 92804
        • Research Site
      • Downey, California, United States, 90240
        • Research Site
      • National City, California, United States, 91950
        • Research Site
      • Paramount, California, United States, 90723
        • Research Site
      • West Covina, California, United States, 91790
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80015
        • Research Site
      • Colorado Springs, Colorado, United States, 80922
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32653
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Miami, Florida, United States, 33142
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
      • Fort Gordon, Georgia, United States, 30905
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Oak Lawn, Illinois, United States, 60453
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Research Site
      • Lexington, Kentucky, United States, 40517
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Research Site
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New Mexico
      • Gallup, New Mexico, United States, 87301
        • Research Site
      • Shiprock, New Mexico, United States, 87420
        • Research Site
    • New York
      • Syracuse, New York, United States, 13210
        • Research Site
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Cleveland, Ohio, United States, 44109
        • Research Site
      • Cleveland, Ohio, United States, 44121
        • Research Site
      • Columbus, Ohio, United States, 43205
        • Research Site
      • Dayton, Ohio, United States, 45406
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Research Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Research Site
      • Memphis, Tennessee, United States, 38103
        • Research Site
      • Tullahoma, Tennessee, United States, 37388
        • Research Site
    • Texas
      • Baytown, Texas, United States, 77521
        • Research Site
      • Dallas, Texas, United States, 75251
        • Research Site
      • Edinburg, Texas, United States, 78539
        • Research Site
      • League City, Texas, United States, 77573
        • Research Site
      • Longview, Texas, United States, 75605
        • Research Site
      • Pearland, Texas, United States, 77584
        • Research Site
      • San Antonio, Texas, United States, 78249
        • Research Site
      • San Antonio, Texas, United States, 78240
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research Site
    • Utah
      • Layton, Utah, United States, 84041
        • Research Site
      • Roy, Utah, United States, 84067
        • Research Site
      • Saint George, Utah, United States, 84790
        • Research Site
      • Salt Lake City, Utah, United States, 84107
        • Research Site
      • Salt Lake City, Utah, United States, 84123
        • Research Site
      • South Jordan, Utah, United States, 84095
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Research Site
      • Richmond, Virginia, United States, 23219
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Through 150 Days Post Dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Through 150 Days Post Dose
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
By visit until day 360 post dose
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
From baseline to 360 day post dose visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Through 150 Days Post Dose
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)
Through 150 Days Post Dose
Number of Participants With Disease From the 2nd RSV Season (All Subjects)
Time Frame: From Day 361 to Day 510 Post Dose
From Day 361 to Day 510 Post Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5290C00004
  • 2019-000114-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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