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)

About this Study

This study will evaluate the safety and tolerability of MEDI8897 compared to palivizumab in preterm infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season.

Sponsor Protocol ID:D5290C00005
IRB Number:2019-0209
Actively Enrolling
Phase 2
November 25, 2019
Eligibility Criteria
Both Male and Female

Inclusion CriteriaSubjects must meet all of the following 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: (a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or 
(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone 

2 For the CLD/CHD cohort: 
(a) 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 
(b) 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 CriteriaAny of the following would exclude the subject from participation in the study: 

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

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