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.
Infants born ≤ 35 wGA and are < 6 months of age at enrolment.
Children < 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.
Children < 24 months of age and with haemodynamically significant CHD.
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.
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 < 6 months after enrolment in the trial.
Single group
Palivizumab 15 mg/kg
DrugSingle-dose liquid solution vials, 50 mg/0.5 mL, IM injection
To assess the safety of palivizumab prophylaxis when administered to preterm infants (≤ 35 wGA), children with BPD (< 24 months) and/or children with haemodynamically significant CHD (< 24 months).
1\) To determine percentage of participants with AEs and SAEs. 2) To assess nature, incidence, and severity of all AEs including unexpected adverse drug reactions 2)To determine percentage of participants with AEs that lead to study intervention discontinuation.
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