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: 10042613 - Surgical and medical procedures
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations 2. Japanese infants of =12 months of age eligible to receive palivizumab in accordance with national or local guidelines and those who must meet at least one of the following conditions at the time of informed consent. - Immunodeficiency - Chronic Lung Disease - Congenital Heart Disease - Down syndrome - Born pre-term =28 wks Gestation age and aged =12 months, or born pre-term >28 wks and =35 wks Gestation age and aged =6 months 3. The participant's parent(s)/legally authorized representative(s) can understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator. 4. The participant is available to complete the follow-up period for approximately 19 months, which will be approximately 1 year after receipt of 2nd dose of nirsevimab Are the trial subjects under 18? yes Number of subjects for this age range: 33 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. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment 2. A current, active RSV infection at the time of screening and investigational product administration 3. Any fever (=100.4°F [=38.0°C], regardless of route) or acute illness at the time of prior to investigational product administration 4. Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including: - Known renal impairment - Known hepatic dysfunction including known or suspected active or chronic hepatitis infection - Any seizure disorder or evolving or unstable neurological condition 5. Anticipated cardiac surgery within 5-6 months after enrollment 6. Prior history of a suspected or actual acute life-threatening event 7. Receipt or intended use of palivizumab in the current enrollment season 8. Any known allergy or history of allergic reaction to any component of nirsevimab 9. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins 10. Concurrent enrollment in another interventional study, or prior receipt of any investigational agent 11. Anticipated survival of less than 1 year at the time of informed consent 12. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results 13. 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 2 doses of nirsevimab administered 5 to 6 months apart;Secondary Objective: 1. To evaluate the PK of 2nd dose of nirsevimab administered 5 to 6 months after the first dose 2. To evaluate ADA responses to 2 doses of nirsevimab administered 5 to 6 months apart 3. To determine anti-RSV neutralizing antibody (Ab) levels in serum to 2 doses of nirsevimab administered 5 to 6 months apart;Primary end point(s): Incidence of all treatmentemergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new-onset chronic diseases (NOCDs) through 360 days post 2nd dose;Timepoint(s) of evaluation of this end point: From dosing through to 360 days after the 2nd or last dose administered in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pharmacokinetics (PK) - Nirsevimab serum concentrations 2. ADA - Occurrence of ADA to nirsevimab in serum 3. Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum;Timepoint(s) of evaluation of this end point: 1. Day 1 pre-dose, Day 151 (pre dose 2), Day 181, Day 301 and Day 511 2. Day 1 pre-dose, Day 151 (pre dose 2), Day 181, Day 301 and Day 511 3. Day 1 pre-dose, Day 151 (pre dose 2), Day 181, Day 301 and Day 511 | — |
Countries
Japan
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed