jRCT2031230256进行中（未招募）不适用
A Phase III, Single-Arm, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Anti-Drug Antibody, and Anti-RSV Neutralizing Antibody Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants with Congenital Heart Disease, Chronic Lung Disease, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan (JUBILUS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 主要终点
- Incidence of all treatment-emergent adverse events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 12month old under（—）
- 性别
- All
入选标准
- •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.
- •(a)Immunodeficiency
- •(b)Chronic Lung Disease
- •(c)Congenital Heart Disease
- •(d)Down syndrome
- •(e)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.
排除标准
- •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 (>=100.4F [>=38.0C], 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:
- •(a)Known renal impairment
- •(b)Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- •(c)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
结局指标
主要结局
Incidence of all treatment-emergent adverse events (TEAEs)
时间窗: through 360 days post 2nd dose
Incidence of all treatment-emergent adverse events
Incidence of new-onset chronic diseases (NOCDs)
时间窗: through 360 days post 2nd dose
Incidence of new-onset chronic diseases
Incidence of treatment-emergent serious adverse events (TESAEs)
时间窗: through 360 days post 2nd dose
Incidence of treatment-emergent serious adverse events
Incidence of adverse events of special interest (AESIs)
时间窗: through 360 days post 2nd dose
Incidence of adverse events of special interest
次要结局
未报告次要终点
研究者
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