Overview

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:
Active, not recruiting
Trial end date:
2022-11-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MedImmune LLC
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunoglobulins
Palivizumab
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