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. Healthy infants in their first year of life and born = 35 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible) 2. Infants who are entering their first RSV season at the time of screening 3. 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 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 17 months after receipt of study drug Are the trial subjects under 18? yes Number of subjects for this age range: 3000 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 national or other local criteria to receive commercial palivizumab 2. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization 3. Any history of LRTI or active LRTI prior to, or at the time of, randomization 4. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization 5. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) 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, blood products, 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. CHD, 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 mAb or any RSV vaccine, including maternal RSV vaccination 20. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MEDI8897 when administered as a single fixed IM dose to infants = 35 weeks 0 days GA and entering their first RSV season, in reducing medically attended LRTI due to RT-PCR-confirmed RSV, compared to placebo;Secondary Objective: 1. To assess the efficacy of MEDI8897 in reducing hospitalizations 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 through 150 days after dosing (ie, during a typical 5-month RSV season);Timepoint(s) of evaluation of this end point: 150 days after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season) 2. Safety and tolerability of MEDI8897 as assessed by the occurrence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) 3. Summary of MEDI8897 serum concentrations and estimated PK parameters: apparent clearance, AUC0-8, if data permit 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 TEAEs, TESAEs, AESIs, and NOCDs, will be assessed through Day 361. Blood will be collected to evaluate the PK of MEDI8897 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). ADA will be measured at screening and at Day151 and Day 361 and as needed (ADA samples will be collected for subjects hospitalised with LRTI). | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, 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