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
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 110
- 试验地点
- 9
- 主要终点
- Presence of immediate adverse events (AEs)
研究概览
简要总结
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months 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.
详细描述
Study duration: up to 16 months, including 10 months of enrollment and 6 months of follow-up
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Treatment duration: 1 day; 1 intramuscular (IM) injection
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Visit frequency:
-
1 in-person visit for immunization (Visit [V] 01) at Day (D) 1.
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3 phone call visits (V2, V3 and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181 (+14 days) respectively.
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
入排标准
- 年龄范围
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
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
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •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 ≥ 38.0°C [≥ 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
- •Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Nirsevimab
Participants will receive:
- 1 intramuscular (IM) injection for neonates and infants aged 0 to 12 months born or entering their first RSV season at Day 01
- 2 IM injections for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season at Day 01
干预措施: Nirsevimab (Biological)
结局指标
主要结局
Presence of immediate adverse events (AEs)
时间窗: Within 30 minutes after immunization
Number of participants experiencing immediate AEs
Presence of non-serious AEs
时间窗: From Day 01 through Day 31
Number of participants experiencing non-serious AEs
Presence of adverse events of special interest (AESIs) throughout the study
时间窗: Throughout the study (approximately 6 months)
Number of participants experiencing AESIs
Presence of medically attended adverse events (MAAEs) throughout the study
时间窗: Throughout the study (approximately 6 months)
Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs) throughout the study
时间窗: Throughout the study (approximately 6 months)
Number of participants experiencing SAEs
次要结局
- Incidence of medically attended lower respiratory tract infection (LRTI) (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV(Through 180 days after dosing)
- Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing(Through 180 days after dosing)