A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Incidence of all TEAEs, TESAEs, AESIs, and NOCDs
研究概览
简要总结
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
Study details include
- The study duration is approximately 21 months with a 2-month enrollment period.
- Study intervention is 2 doses administered 5- 6 months apart.
- The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking is used. All involved know the identity of the intervention assignment.
入排标准
- 年龄范围
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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.
- •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
排除标准
- •Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
- •A current, active RSV infection at the time of screening and investigational product administration
- •Any fever (≥100.4°F [≥38.0°C], regardless of route) or acute illness at the time of prior to investigational product administration
- •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
- •Anticipated cardiac surgery within 5-6 months after enrollment
- •Prior history of a suspected or actual acute life-threatening event
- •Receipt or intended use of palivizumab in the current enrollment season
- •Any known allergy or history of allergic reaction to any component of nirsevimab
- •Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
- •Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
- •Anticipated survival of less than 1 year at the time of informed consent
- •Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results
- •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
研究组 & 干预措施
MEDI8897
Anti-RSV monoclonal antibody
干预措施: Nirsevimab (Drug)
结局指标
主要结局
Incidence of all TEAEs, TESAEs, AESIs, and NOCDs
时间窗: 360 days after the 2nd or last dose administered in the study
The number and percentage of participants with TEAEs, TESAEs, AESIs, and NOCDs will be summarized by SOC and PT overall.
Study discontinuations prior to Day 151 post 2nd dose.
时间窗: 360 days after the 2nd or last dose administered in the study
The number and percentage of subject discontinuations will be summarized.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
时间窗: From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511
An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.
次要结局
- Pharmacokinetics (PK) - Nirsevimab serum concentrations(360 days after the 2nd or last dose administered in the study)
- ADA - Occurrence of ADA to nirsevimab in serum(360 days after the 2nd or last dose administered in the study)
- Anti-RSV neutralizing Ab - Anti-RSV neutralizing Ab levels (IU/mL) in serum(360 days after the 2nd or last dose administered in the study)
- Serum Concentrations of Nirsevimab(Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose)
- Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab(Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose)
- Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels(Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose)