NCT06851806

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
DRUG	Palivizumab 15 mg/kg	Single-dose liquid solution vials, 50 mg/0.5 mL, IM injection

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2025-02-28
• Last updated: 2026-04-17

Locations

2 sites across 1 country: India