Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
Trial Parameters
Brief Summary
This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg/kg IM injection once a month for up to 5 injections during the study. Children who undergo cardiac surgery with cardiopulmonary bypass during the study should receive an additional dose of study intervention immediately after surgery, when medically stable for IM injection as determined by the physician. Prior to each study intervention administration, all participants will undergo safety assessments. A follow-up visit will be performed telephonically with the parent(s) or legal guardian(s) of all participants 30 days after their last injection of palivizumab.
Eligibility Criteria
Inclusion Criteria: 1. Participants at risk of severe RSV disease defined as fulfilling at least one of the following: 1. Infants born ≤ 35 wGA and are \< 6 months of age at enrolment. 2. Children \< 24 months of age at enrolment and requiring treatment for BPD within the last 6 months. 3. Children \< 24 months of age and with haemodynamically significant CHD. 2. Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment 2. Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolmen