A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
2 other identifiers
interventional
925
25 countries
126
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
Typical duration for phase_2
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedSeptember 21, 2023
September 1, 2023
1.8 years
May 21, 2019
August 16, 2023
September 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
360 days post first dose
Secondary Outcomes (3)
Serum Concentrations of MEDI8897 and Palivizumab
Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
360 days post first dose
Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose
150 days post first dose
Study Arms (2)
MEDI8897
EXPERIMENTALanti-RSV monoclonal antibody with an extended half-life
Palivizumab
ACTIVE COMPARATORanti-RSV monoclonal antibody
Interventions
Eligibility Criteria
You may qualify if:
- For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
- Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
- Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
- For the CLD/CHD cohort:
- Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
- Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
- Infants who are entering their first RSV season at the time of screening
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
- Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
- Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
You may not qualify if:
- Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to randomization
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
- Anticipated cardiac surgery within 2 weeks after randomization
- Anticipated survival of \< 6 months after randomization
- Receipt of any investigational drug
- Known renal impairment
- Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- Clinically significant congenital anomaly of the respiratory tract
- Chronic seizure, or evolving or unstable neurologic disorder
- Prior history of a suspected or actual acute life-threatening event
- Known immunodeficiency, including human immunodeficiency virus (HIV)
- Mother with HIV infection (unless the child has been proven to be not infected)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (128)
Research Site
Anaheim, California, 92804, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90027, United States
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National City, California, 91950, United States
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Paramount, California, 90723, United States
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West Covina, California, 91790, United States
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Aurora, Colorado, 80045, United States
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Colorado Springs, Colorado, 80922, United States
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Washington D.C., District of Columbia, 20016, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Indianapolis, Indiana, 46202, United States
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South Bend, Indiana, 46617, United States
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West Des Moines, Iowa, 50266, United States
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Louisville, Kentucky, 40202, United States
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Jackson, Mississippi, 39216, United States
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Columbia, Missouri, 65201, United States
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Mineola, New York, 11501, United States
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Syracuse, New York, 13210, United States
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Durham, North Carolina, 27710, United States
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Greenville, North Carolina, 27834, United States
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Cincinnati, Ohio, 45229, United States
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Columbus, Ohio, 43205, United States
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Greenville, South Carolina, 29607, United States
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Corpus Christi, Texas, 78411, United States
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Layton, Utah, 84041, United States
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St. George, Utah, 84790, United States
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Charlottesville, Virginia, 22902, United States
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Seattle, Washington, 98105, United States
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Morgantown, West Virginia, 26506, United States
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Graz, 8036, Austria
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Montana, 3400, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4003, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1407, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Edmonton, Alberta, T6G 1C9, Canada
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Vancouver, British Columbia, V6H 3V4, Canada
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Prague, 14710, Czechia
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Tampere, 33100, Finland
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Amiens, 80054, France
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Bordeaux, 33000, France
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Brest, 29609, France
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Bron, 69677, France
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Caen, 1403, France
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Créteil, 94010, France
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Grenoble, 38043, France
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Marseille, 13015, France
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Pau, 64046, France
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Frankenthal, 67227, Germany
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Leipzig, 04103, Germany
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Mannheim, 68161, Germany
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Baja, 6500, Hungary
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Budapest, 1096, Hungary
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Debrecen, 4032, Hungary
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Kecskemét, 6000, Hungary
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Miskolc, 3526, Hungary
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Pisa, 56126, Italy
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Verona, 37126, Italy
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Fukui-shi, 918-8503, Japan
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Fukuoka, 813-0017, Japan
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Kitakyusyu-shi, 806-8501, Japan
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Maebashi, 371-0811, Japan
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Saitama Shi, 336 8522, Japan
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Setagaya-ku, 157-8535, Japan
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Jēkabpils, LV-5201, Latvia
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Riga, 1004, Latvia
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Riga, LV1002, Latvia
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Kaunas, 48259, Lithuania
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Kaunas, 50161, Lithuania
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Cuernavaca, 62290, Mexico
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México, 06720, Mexico
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Christchurch, 8011, New Zealand
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Bydgoszcz, 85 168, Poland
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Gdansk, 80-214, Poland
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Krakow, 30-348, Poland
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Krakow, 31-624, Poland
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Wroclaw, 51-169, Poland
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Kazan', 420012, Russia
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Novosibirsk, 630089, Russia
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Perm, 614066, Russia
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Saint Petersburg, 191025, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 197341, Russia
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Yaroslavl, 150003, Russia
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Cape Town, 7505, South Africa
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Cape Town, 7800, South Africa
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Johannesburg, 2112, South Africa
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Johannesburg, 2193, South Africa
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Pretoria, 0087, South Africa
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Pretoria, 0101, South Africa
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Soweto, 2013, South Africa
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Ansan-si, 15355, South Korea
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Seoul, 06351, South Korea
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Suwon, 16499, South Korea
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Alicante, 03010, Spain
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Boadilla del Monte, 28660, Spain
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Elche, 03203, Spain
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Leganés, 28911, Spain
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Lleida, 25198, Spain
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Madrid, 28046, Spain
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Málaga, 29004, Spain
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Pozuelo de Alarcón, 28223, Spain
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Sant Cugat del Vallès, 08190, Spain
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Tarragona, 43007, Spain
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Stockholm, 118 83, Sweden
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Adana, 01330, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Chernivtsі, 58001, Ukraine
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Dnipro, 49006, Ukraine
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Ivano-Frankivsk, 76014, Ukraine
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Kharkiv Region, 61093, Ukraine
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Odesa, 65031, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21000, Ukraine
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Leicester, LE3 9QP, United Kingdom
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London, W2 1NY, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
Related Publications (1)
Domachowske J, Madhi SA, Simoes EAF, Atanasova V, Cabanas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186. No abstract available.
PMID: 35235733DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 22, 2019
Study Start
July 30, 2019
Primary Completion
May 3, 2021
Study Completion
January 20, 2023
Last Updated
September 21, 2023
Results First Posted
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.