A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Percentage of Participants With RSV Hospitalization
研究概览
简要总结
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease [CHD]).
详细描述
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- •Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment
- •Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment
- •Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage hemodynamically significant CHD
- •Exclusion Criteria (main exclusion criteria):
- •Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days)
- •Mechanical ventilation (including continuous positive airway pressure, CPAP) at the time of enrollment
- •Life expectancy less than 6 months
- •Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
- •Active respiratory illness, or other acute infection
排除标准
- 未提供
研究组 & 干预措施
Children at High Risk of severe RSV Infection
A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
干预措施: Palivizumab (Drug)
结局指标
主要结局
Percentage of Participants With RSV Hospitalization
时间窗: Approximately 6 months
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
次要结局
- Total Number of RSV-Hospitalization Days(Approximately 6 months)
- Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement(Approximately 6 months)
- Percentage of Participants Who Received Supplemental Oxygen While Hospitalized(Approximately 6 months)
- Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization(Approximately 6 months)
- Total Days of Mechanical Ventilation During RSV-hospitalization(Approximately 6 months)
- Total Days of RSV-ICU Stay(Approximately 6 months)
- Percentage of Participants Who Received Mechanical Ventilation(Approximately 6 months)