A Phase 2, Open-label study to find how safe and effective Nirsevimab is in preventing serious Respiratory Syncytial Virus (RSV) disease in Immunocompromised children = 24 months of age.

Phase 1

Conditions: RSV disease
MedDRA version: 21.1Level: LLTClassification code 10066742Term: Respiratory syncytial virus infection prophylaxisSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2021-003221-30-PL

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Neonate, infant, or young child = 24 months of age who, per investigator judgment, are:
(a)In their first year of life AND entering their first RSV season at the time of dose administration
OR
(b)In their second year of life AND entering their second RSV season at the time of dose administration
2.The subject must meet at least 1 of the following conditions at the time of informed consent.
(a)Diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M [IgM] syndrome, etc); antibody deficiency (X linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc), or
(b)Diagnosed with human immunodeficiency virus infection, or
(c)History of organ or bone marrow transplantation, or
(d)Subject is receiving immunosuppressive chemotherapy, or
(e)Subject is receiving systemic high-dose corticosteroid therapy (prednisone equivalents = 0.5 mg/kg every other day, other than inhaler or topical use), or
(f)Subject is receiving other immunosuppressive therapy (eg, azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc)
All efforts will be made to recruit subjects for representation across all the immunocompromised conditions indicated in inclusion criteria (a) - (f).
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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

1.Subject who meets any of the indications other than (including those approved for palivizumab in Japan) the immunocompromised conditions below.
(a)Subject born at = 28 weeks gestation and is = 12 months of age
(b)Subject born at 29 to 35 weeks gestation and is = 6 months of age
(c)Age = 24 months with a history of bronchopulmonary dysplasia requiring medical management within the past 6 months
(d)Age = 24 months with current hemodynamically significant CHD
(e)Age = 24 months with Down syndrome
2.Requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, or other mechanical respiratory or cardiac support at screening.
3.A current, active infection, including RSV infection, at the time of screening or at the time of investigational product administration.
4.Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration.
5.Any serious concurrent medical condition (renal failure, hepatic dysfunction, suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic disorder, etc), except those resulting in an immune deficiency condition.
6.Clinically significant congenital anomaly of the respiratory tract.
7.Receipt of palivizumab.
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of nirsevimab when administered to immunocompromised children = 24 months of age;Secondary Objective: PK: To evaluate the PK of nirsevimab<br>ADA: To evaluate ADA responses to nirsevimab in serum<br>Efficacy: To assess the efficacy of nirsevimab when administered as a single IM dose to infants = 24 months of age;Primary end point(s): All TEAEs, TESAEs, AESIs, and NOCDs;Timepoint(s) of evaluation of this end point: Through 360 days after dosing

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PK: Summary of nirsevimab serum concentrations<br>ADA: Incidence of ADA to nirsevimab in serum<br>Efficacy: Incidence of medically attended LRTI (inpatient and outpatient) and hospitalizations due to RT-PCR-confirmed RSV through 150 days after administration of nirsevimab;Timepoint(s) of evaluation of this end point: PK, ADA through 360 days after dosing.<br>Efficacy through 150 days after dosing.

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