A Phase 4, open-label, single-arm clinical study to describe safety and efficacy outcomes associated with the use of nirsevimab in neonates and infants born during or entering their first respiratory syncytial virus (RSV) season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- To describe the safety outcomes associated with the use of nirsevimab injection in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
研究概览
简要总结
he purpose of this study isto describe the safety and efficacy outcomes associated with the use ofnirsevimab, administered as per routine clinical practice, in neonates andinfants aged 0 to 12 months born during or entering their first RSV season andin children up to 24 months of age who remain vulnerable to severe RSV diseasethrough their second RSV season.
Study details include:
• Study duration: up to 16months, including 10 months of enrollment and 6 months of follow-up
• Treatment duration: 1 day;1 or 2 IM injections
• Visit frequency:
1 in-person visit forimmunization (V1) at D01.
3 phone call visits (V2, V3and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181(+ 14 days) respectively.
Additional LRTI visits mayoccur during the study in case of LRTI symptoms. All participants seekingmedical attention for a respiratory illness (in either the inpatient or outpatientsetting) will be evaluated for the occurrence of LRTI.
Parents/LARs will inform thesite if the participant experiences any LRTI symptoms. The site staff shouldverify information on LRTI symptoms and, if an RSV-LRTI is suspected, schedulean appointment for a nasal swab as soon as possible and preferably within 2days of the initial healthcare provider assessment.
In that case, an LRTI visitform will be completed in the
eCRF and informationon clinical manifestations, including respiratory symptoms and fever will becollected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Neonates and infants aged 0 to 12 months on the day of inclusion and born during or entering their first RSV season OR children up to 24 months of age on the day of inclusion who remain vulnerable to severe RSV disease through their second RSV season.
- •Informed consent form has been signed and dated by the participant’s parent(s) or other legally acceptable representative(s).
- •Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
- •Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s), contraindicating intramuscular injection.
- •Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection.
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- •Active LRTI on the day of study intervention administration.
- •Active RSV infection on the day of study intervention administration.
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature more than equal to 38.0°C [more than equal to 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine in the same RSV season than inclusion in the study.
- •Mother of the participant was administered an RSV vaccine during her pregnancy with the participant.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- •Receipt of any investigational drug in the last 30 days prior to the inclusion in the study.
- •Participation at the time of study enrollment or in the 4 weeks preceding the study intervention administration or planned participation during the present study period, in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •Being in an emergency setting.
- •Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study.
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
结局指标
主要结局
To describe the safety outcomes associated with the use of nirsevimab injection in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
时间窗: 181 days
次要结局
- To describe the occurrence of medically attended RSV lower respiratory tract infection (LRTI) in neonates and infants(born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe)