The prevention of medically attended RSV LRTI. MedDRA version: 21.1 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 100000004865
Conditions
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects 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 Are the trial subjects under 18? yes Number of subjects for this age range: 925 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any 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 < 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to high-risk infants eligible to receive palivizumab entering their first RSV season and children with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first and second RSV season.;Secondary Objective: 1. To evaluate serum concentrations of MEDI8897 and palivizumab 2. To evaluate ADA responses to MEDI8897 and to palivizumab in serum 3. To assess the descriptive efficacy of MEDI8897 when administered as a single IM dose in the first RSV season or a single IM dose administered in the second RSV season, in reducing medically attended LRTI (inpatient and outpatient) and hospitalization due to RT-PCR-confirmed RSV, compared to palivizumab;Primary end point(s): Safety and tolerability of MEDI8897 as 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).;Timepoint(s) of evaluation of this end point: Occurrence of all TEAEs, TESAEs, AESIs, and NOCDs, will be assessed through the follow-up period (Day 361). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. a. MEDI8897 and palivizumab serum concentrations b. MEDI8897 and palivizumab PK parameters: Summary of serum concentrations and estimated PK parameters (Cmax, AUC, apparent clearance, and t1/2, if data permit) 2. Incidence of ADA to MEDI8897 and palivizumab in serum 3. a. 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 b. Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2;Timepoint(s) of evaluation of this end point: 1. Blood will be collected to evaluate the PK of MEDI8897 and palivizumab in serum at screening and on Day 15, Day 151, Day 361 and as needed (PK samples will be collected for subjects hospitalised with LRTI) for season 1 and season 2 (CLD/CHD Cohort Only). Subjects requiring a replacement dose of study drug due to cardiac surgery with cardiopulmonary bypass will have a blood sample collected before and after surgery (prior to administering replacement dose) for PK evaluation. 2. ADA will be measured at screening and on Day 151 and Day 361 and as needed (ADA samples will be collected for subjects hospitalised with LRTI). 3. Incidence of LRTI and hospitalizations due to RSV will be monitored through Day 151 post dose in Season 1 and Season 2. | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Center
MedImmune, LLC
Outcome results
None listed