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

  • STATUS
    Recruiting
  • End date
    Dec 3, 2021
  • participants needed
    1500
  • sponsor
    MedImmune LLC
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Updated on 16 January 2021
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Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (5.8 mi away) Contact
+340 other location
chronic disease
diuretics
bronchodilator
palivizumab

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.

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).

Details
Treatment Palivizumab, MEDI8897
Clinical Study IdentifierNCT03959488
SponsorMedImmune LLC
Last Modified on16 January 2021

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Eligibility

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Inclusion Criteria

Is your age less than or equal to 1 yrs?
Gender: Male or Female
Do you have Respiratory syncytial virus infection?
Do you have any of these conditions: Respiratory syncytial virus infection or rsv infection?
Do you have any of these conditions: rsv infection or Respiratory syncytial virus infection?
Do you have any of these conditions: Respiratory syncytial virus infection or rsv infection?
Do you have any of these conditions: rsv infection or Respiratory syncytial virus infection?
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

Exclusion Criteria

Any fever ( 100.4F [ 38.0C], 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)
Any known allergy, including to immunoglobulin products, or history of allergic reaction
Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
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
Concurrent enrollment in another interventional study
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
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