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

September 20, 2023 updated by: AstraZeneca

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)

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.

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 study is a pivotal Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety, pharmacokinetics (PK), anti-drug antibody (ADA) response, and descriptive efficacy for MEDI8897 in high-risk infants eligible to receive palivizumab when entering their first or second RSV season (Season 1 or Season 2, respectively). Approximately 900 palivizumab-eligible infants entering their first RSV season will be enrolled into one of 2 cohorts: (1) preterm cohort, including approximately 600 preterm infants (≤ 35 weeks gestational age [GA]) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 300 infants with CLD of prematurity or hemodynamically significant CHD. A minimum of 100 infants with hemodynamically significant CHD will be enrolled. Within each cohort, randomization will be stratified by hemisphere (northern, southern) and subject age at the time of Season 1 randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months).

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.
925

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 2
  • 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

  • Austria
      • Graz, Austria, 8036
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • 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, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Ruse, Bulgaria, 7002
        • Research Site
      • Sliven, Bulgaria, 8800
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1309
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Research Site
  • Czechia
      • Praha 4, Czechia, 14710
        • Research Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Research Site
      • Tartu, Estonia, 51014
        • Research Site
  • Finland
      • Tampere, Finland, 33100
        • 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, 1403
        • Research Site
      • Creteil Cedex, France, 94010
        • Research Site
      • Grenoble Cedex 9, France, 38043
        • Research Site
      • Marseille, France, 13015
        • Research Site
      • Pau Cedex, France, 64046
        • Research Site
  • Germany
      • Frankenthal, Germany, 67227
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Mannheim, Germany, 68161
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1096
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
  • Italy
      • Pisa, Italy, 56126
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Japan
      • Fukui-shi, Japan, 918-8503
        • Research Site
      • Fukuoka-shi, Japan, 813-0017
        • Research Site
      • Kitakyusyu-shi, Japan, 806-8501
        • Research Site
      • Maebashi-shi, Japan, 371-0811
        • Research Site
      • Saitama shi, Japan, 336 8522
        • Research Site
      • Setagaya-ku, Japan, 157-8535
        • Research Site
  • Korea, Republic of
      • Ansan-si, Korea, Republic of, 15355
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
  • Latvia
      • Jekabpils, Latvia, LV-5201
        • Research Site
      • Riga, Latvia, 1004
        • Research Site
      • Riga, Latvia, LV1002
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 48259
        • Research Site
      • Kaunas, Lithuania, 50161
        • Research Site
  • Mexico
      • Cuernavaca, Mexico, 62290
        • Research Site
      • Mexico, Mexico, 06720
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85 168
        • Research Site
      • Gdańsk, Poland, 80-214
        • Research Site
      • Krakow, Poland, 31-624
        • Research Site
      • Kraków, Poland, 30-348
        • Research Site
      • Wrocław, Poland, 51-169
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Research Site
      • Novosibirsk, Russian Federation, 630089
        • Research Site
      • Perm, Russian Federation, 614066
        • Research Site
      • Saint Petersburg, Russian Federation, 197341
        • Research Site
      • Saint Petersburg, Russian Federation, 191025
        • Research Site
      • St Petersburg, Russian Federation, 193312
        • Research Site
      • Yaroslavl, Russian Federation, 150003
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7505
        • Research Site
      • Cape Town, South Africa, 7800
        • 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
      • Soweto, South Africa, 2013
        • Research Site
  • Spain
      • Alicante, Spain, 03010
        • Research Site
      • Boadilla del Monte, Spain, 28660
        • Research Site
      • Elche, Spain, 03203
        • Research Site
      • Leganes, Spain, 28911
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Malaga, Spain, 29004
        • Research Site
      • Pozuelo de Alarcon, Spain, 28223
        • Research Site
      • Sant Cugat del Valles, Spain, 08190
        • Research Site
      • Tarragona, Spain, 43007
        • Research Site
  • Sweden
      • Stockholm, Sweden, 118 83
        • Research Site
  • Turkey
      • Adana, Turkey, 01330
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58001
        • Research Site
      • Dnipro, Ukraine, 49006
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76014
        • Research Site
      • Kharkiv Region, Ukraine, 61093
        • Research Site
      • Odesa, Ukraine, 65031
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site
      • Vinnytsia, Ukraine, 21000
        • Research Site
  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Research Site
      • London, United Kingdom, W2 1NY
        • Research Site
      • Nottingham, United Kingdom, NG7 2UH
        • Research Site
  • United States
    • California
      • Anaheim, California, United States, 92804
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Los Angeles, California, United States, 90027
        • 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, 80045
        • Research Site
      • Colorado Springs, Colorado, United States, 80922
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
      • South Bend, Indiana, United States, 46617
        • Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Columbus, Ohio, United States, 43205
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Research Site
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Research Site
    • Utah
      • Layton, Utah, United States, 84041
        • Research Site
      • Saint George, Utah, United States, 84790
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • 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

No

Description

Inclusion criteria

  1. 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:

    1. Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
    2. Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone

  2. For the CLD/CHD cohort:

    1. 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
    2. 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
  3. Infants who are entering their first RSV season at the time of screening
  4. 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
  5. 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
  6. 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

Exclusion criteria

  1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
  2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
  3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
  4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
  5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
  6. Anticipated cardiac surgery within 2 weeks after randomization
  7. Anticipated survival of < 6 months after randomization
  8. Receipt of any investigational drug
  9. Known renal impairment
  10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
  11. Clinically significant congenital anomaly of the respiratory tract
  12. Chronic seizure, or evolving or unstable neurologic disorder
  13. Prior history of a suspected or actual acute life-threatening event
  14. Known immunodeficiency, including human immunodeficiency virus (HIV)
  15. Mother with HIV infection (unless the child has been proven to be not infected)
  16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
  17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
  18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
  19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
  20. Concurrent enrollment in another interventional study
  21. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

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
Active Comparator: Palivizumab
anti-RSV monoclonal antibody
Drug: Palivizumab
Approved anti-RSV monoclonal antibody

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
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)
Time Frame: 360 days post first dose
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 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
Serum Concentrations of MEDI8897 and Palivizumab
Time Frame: Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Summary of individual MEDI8897 and palivizumab serum concentration data by treatment group along with descriptive statistics.
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
Time Frame: 360 days post first dose
Incidence of ADA to MEDI8897 and palivizumab as assessed by the percentage of participants with any post-baseline ADA positive by treatment group.
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
Time Frame: 150 days post first dose
Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2. Incidence of LRTI hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for season 1 and season 2.
150 days post first 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 30, 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.
May 3, 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.
January 20, 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 21, 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.
May 21, 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.
May 22, 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.
September 21, 2023

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.
September 20, 2023

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.
September 1, 2023

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.
  • D5290C00005
  • 2019-000201-69 (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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings