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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

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ClinicalTrials.gov Identifier: NCT03959488
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
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 1,500 palivizumab-eligible infants entering their first RSV season will be enrolled into one of 2 cohorts : (1) preterm cohort, including approximately 750 preterm infants (≤ 35 weeks GA) without CLD/CHD, or (2) CLD/CHD cohort, including approximately 750 infants with CLD of prematurity or hemodynamically significant CHD. As 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Syncytial Virus Infections
Intervention  ICMJE
  • Drug: MEDI8897
    Anti-RSV monoclonal antibody with an extended half-life
  • Drug: Palivizumab
    Approved anti-RSV monoclonal antibody
Study Arms  ICMJE
  • Experimental: MEDI8897
    anti-RSV monoclonal antibody with an extended half-life
    Intervention: Drug: MEDI8897
  • Active Comparator: Palivizumab
    anti-RSV monoclonal antibody
    Intervention: Drug: Palivizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 3, 2021
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Estonia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   New Zealand,   Panama,   Poland,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959488
Other Study ID Numbers  ICMJE D5290C00005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP