Medically attended Respiratory Syncytial Viral (RSV) Lower respiratory tract infection(LRTI) MedDRA version: 21.1 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 100000004865
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese preterm and term infants in their first year of life and born = 29 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 obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations 4. Subject’s parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the Investigator 5. Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product Are the trial subjects under 18? yes Number of subjects for this age range: 800 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: 1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration 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. 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 5. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator) 6. History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study 7. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization 8. Known renal impairment 9. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 10. History of CLD/bronchopulmonary dysplasia 11. Clinically significant congenital anomaly of the respiratory tract 12. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect) 13. Chronic seizure, or evolving or unstable neurologic disorder 14. Prior history of a suspected or actual acute life-threatening event 15. Known immunodeficiency, including human immunodeficiency virus (HIV) 16. Mother with HIV infection (unless the child has been proven to be not infected) 17. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins, or history of allergic reaction 18. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination 19. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) or anticipated use during the study 20. Receipt of any investigational product 21. Concurrent enrollment in another interventional study 22. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of study results 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 nirsevimab in reducing medically attended LRTI due to RT-PCR-confirmed RSV, compared to placebo, when administered as a single fixed IM dose to healthy preterm and term infants born = 29 weeks 0 days GA and entering their first RSV season;Secondary Objective: 1. Efficacy: To assess the efficacy of nirsevimab in reducing hospitalizations due to RT-PCR-confirmed RSV, compared to placebo 2. Safety: To evaluate the safety and tolerability of nirsevimab when administered as a single fixed IM dose, compared to placebo 3. Pharmacokinetics (PK): To evaluate serum concentrations of nirsevimab 4. ADA: To evaluate ADA responses to nirsevimab in serum;Primary end point(s): Efficacy: Incidence of medically attended LRTI (protocol-defined, 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: Day 1 to D151 post dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy: Incidence of hospitalizations due to RT PCR-confirmed RSV LRTI (protocol-defined) through 150 days after dosing (ie, during a typical 5-month RSV season) 2. Safety: Safety and tolerability of nirsevimab 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.PK: Summary of nirsevimab serum concentrations. 4. ADA: Incidence of ADA to nirsevimab in serum.;Timepoint(s) of evaluation of this end point: 1. Efficacy: Day 1 to D151 2. Safety: Day 1 to D361 3. PK: Day 1, D15, D151 & D361 4. ADA:Day 1, D151 & D361 | — |
Countries
China
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed