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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959488
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: MEDI8897 Drug: Palivizumab Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 925 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : May 3, 2021
Estimated Study Completion Date : November 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of MEDI8897 as assessed by the occurence of all treatment emergent adverse events (TEAESs) and treatment emergent serious adverse events (TESAE) [ Time Frame: 360 days post 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)


Secondary Outcome Measures :
  1. Evaluate serum concentrations of MEDI8897 and palivizumab [ Time Frame: 360 days post dose ]
    Individual MEDI8897 and palivizumab serum concentration data will be tabulated by treatment group along with descriptive statistics. PK parameters will be estimated using non compartmental analysis, if data permit.

  2. Incidence of anti-drug antibody to MEDI8897 and palivizumab in serum [ Time Frame: 360 days post dose ]
    The incidence of ADA to MEDI8897 and palivizumab will be assessed and summarized by number and percentage of subjects that are ADA positive by treatment group.

  3. Assess the descriptive efficacy of MEDI8897 in reducing medically attended LRTI incidence and hospitalization due to Reverse Transcriptase Chain Reaction (RT-PCR) confirmed RSV [ Time Frame: 150 days post 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959488


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03959488    
Other Study ID Numbers: D5290C00005
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Respiratory Syncytial Virus Infections
Preterm Infants
Lower Respiratory Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
 Virus Diseases
Disease Attributes
Pathologic Processes
Palivizumab
Antiviral Agents
Anti-Infective Agents