The prevention of medically attending RSV LRTI. MedDRA version: 19.0 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Product Name: MEDI8897
Product Code: MEDI8897
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not available
Current Spo
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA. 2. Infants who are = 8 months of age and entering their first full RSV season at the time of screening. 3. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative prior to performing any protocol-related procedures, including screening evaluations. 4. Subject's parent(s)/legal representative is able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator. 5. Subject is available to complete the follow-up period, which will be 1 year after receipt of the dose of study drug. Are the trial subjects under 18? yes Number of subjects for this age range: 1500 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. Meets AAP or other local criteria to receive commercial palivizumab. 2. Any fever (= 100.4°F [= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomisation. 3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomisation. 4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection. 5. Any drug therapy (chronic or other) within 7 days prior to randomisation or expected receipt during the study with the exception of: 1) multivitamins and iron; 2) infrequent use of over the counter medications for the systemic treatment of common childhood symptoms (eg, pain relievers, decongestants or cough suppressants) that may be permitted according to the judgment of the investigator. 6. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator). 7. History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study. 8. Receipt of any investigational drug. 9. Known renal impairment. 10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection. 11. History of CLD/bronchopulmonary dysplasia. 12. Clinically significant congenital anomaly of the respiratory tract. 13. Chronic seizure or evolving or unstable neurologic disorder. 14. Congenital heart disease, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect). 15. Prior history of a suspected or actual acute life-threatening event. 16. Known immunodeficiency, including human immunodeficiency virus (HIV). 17. Mother with HIV infection (unless the child has been proven to be not infected). 18. Any known allergy, including to immunoglobulin products, or history of allergic reaction. 19. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination. 20. Receipt of any monoclonal or polyclonal antibody (for example, Hepatitis B immune globulin, intravenous immunoglobulin). 21. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. 22. Concurrent enrollment in another interventional study. 23. 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. Note: An individual who initially is excluded from study participation based on one or more of the above time-limited criteria (eg, acute illness) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MEDI8897 when administered as a single 50 mg IM dose to healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA and entering their first RSV season for the reduction of medically attended LRTI due to RT-PCR-confirmed RSV, compared to placebo.; Secondary Objective: 1. To assess the efficacy of MEDI8897 for the reduction of hospitalisations due to RT-PCR-confirmed RSV, compared to placebo. 2. To evaluate the safety and tolerability of MEDI8897 when administered as a single fixed IM dose, compared to placebo. 3. To evaluate single-dose serum concentrations of MEDI8897. 4. To evaluate ADA responses to MEDI8897 in serum. ;Primary end point(s): Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV over the duration of the 5-month RSV season.;Timepoint(s) of evaluation of this end point: 5-month RSV season | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of hospitalisations due to RT-PCR-confirmed RSV over the duration of the 5-month RSV season. 2. 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). 3. Single-dose MEDI8897 serum concentrations. 4. Incidence of ADA to MEDI8897 in serum. ; Timepoint(s) of evaluation of this end point: Subjects will be monitored throughout the study for LRTI. 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), will be assessed throughout the study. Blood will be collected to evaluate the PK of MEDI8897 in serum at screening and on Day 91, Day 151, Day 361 and as needed (PK samples will be collected for subjects hospitalised with LRTI). To determine the duration of MEDI8897 serum levels post dosing and to correlate with the development of ADA, serum concentrations will be measured at 360 days post dosing. ADA will be measured at Day 91, Day151 and Day 361 and as needed (ADA samples will be collected for subjects hospitalised with LRTI). | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactInformation Center
MedImmune, LLC
Outcome results
None listed