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

Completed · Phase 2/Phase 3

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID: NCT03959488
Run by: AstraZeneca
People needed: 925
Starts: 2019-07-30
Expected to finish: 2023-01-20
Last updated by the study team: 2023-09-21

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

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)
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

Where it is running

Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — National City, California, United States
Research Site — Paramount, California, United States
Research Site — West Covina, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Colorado Springs, Colorado, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — South Bend, Indiana, United States
Research Site — West Des Moines, Iowa, United States
Research Site — Louisville, Kentucky, United States
Research Site — Jackson, Mississippi, United States
Research Site — Columbia, Missouri, United States
Research Site — Mineola, New York, United States
Research Site — Syracuse, New York, United States
Research Site — Durham, North Carolina, United States
Research Site — Greenville, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Columbus, Ohio, United States
Research Site — Greenville, South Carolina, United States
Research Site — Corpus Christi, Texas, United States
Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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