A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 4
研究概览
简要总结
This Phase IV, open-label, multicenter study aims to evaluate the safety of palivizumab (SYNAGIS) in preventing severe respiratory syncytial virus (RSV)-related lower respiratory tract disease in high-risk infants and children in India. The study plans to enroll 138 participants, who will receive monthly intramuscular injections of palivizumab (15 mg/kg) for up to five doses during the RSV season. Participants undergoing cardiac surgery with cardiopulmonary bypass may receive an additional dose post-surgery once medically stable. Safety assessments will be conducted prior to each dose, and a follow-up will be performed telephonically 30 days after the final injection. The study is designed to monitor the overall safety profile of palivizumab in the target population, with timelines for first enrollment and study completion yet to be finalized
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 23.00 Month(s)（—）
- 性别
- All
入选标准
- •Infants born greater than equal to 35 wGA and are less than 6 months of age at enrolment Children less than 24 months of age at enrolment and requiring treatment for BPD within the last 6 months Children less than 24 months of age and with haemodynamically significant CHD.
排除标准
- •Hospitalisation at the time of enrolment unless the discharge is expected within 30 days of the time of enrolment Required mechanical ventilation including continuous positive airway pressure or other mechanical respiratory or cardiac support at the time of enrolment Anticipated cardiac surgery within 2 weeks after enrolment Anticipated survival of greater than 6 months after enrolment in the trial Active LRTD including RSV infection at the time of enrolment and or study intervention administration Any fever greater than or equal to 38 degree Celsius or acute illness within 7 days prior to investigational product administration Known history of evolving or unstable neurologic disorder Known history of unstable cardiac or respiratory status including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated Known allergy including to immunoglobulin products or history of allergic reaction Prior or Concurrent Clinical Study Experience Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine including maternal RSV vaccination Receipt of any monoclonal or polyclonal antibody for example hepatitis B immune globulin intravenous immunoglobulin or anticipated use during the study Concurrent enrolment in another interventional study Other Exclusions 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 Judgment by the investigator that the participant should not participate in the study if the participant or the participants parent or legal guardian is unlikely to comply with study procedures restrictions and requirements.
研究者
Dr Suresh Kumar Panuganti
Yashoda Hospital Somajiguda