RecruitingNot ApplicableNCT06851806

Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease

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


Sponsor

AstraZeneca

Enrollment

138 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Palivizumab 15 mg/kg for people with respiratory syncytial virus (rsv). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalivizumab 15 mg/kg

Single-dose liquid solution vials, 50 mg/0.5 mL, IM injection


Locations(6)

Research Site

Hyderabad, India

Research Site

Kanpur, India

Research Site

Kolkata, India

Research Site

Mysore, India

Research Site

Pune, India

Research Site

Vidyanagar, Hubballi, India

View Full Details on ClinicalTrials.gov

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NCT06851806


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