Actively Recruiting
Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
Led by AstraZeneca · Updated on 2026-04-17
138
Participants Needed
2
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at or before 35 weeks gestational age and younger than 6 months at enrollment
- Children younger than 24 months requiring treatment for bronchopulmonary dysplasia within the last 6 months
- Children younger than 24 months with hemodynamically significant congenital heart disease
- Written informed consent from parent or legal guardian who can comply with study requirements including follow-up
You will not qualify if you...
- Hospitalized at enrollment unless discharge expected within 30 days
- Requiring mechanical ventilation or other mechanical respiratory or cardiac support at enrollment
- Planned cardiac surgery within 2 weeks after enrollment
- Expected survival less than 6 months after enrollment
- Active lower respiratory tract disease including RSV infection at enrollment or intervention
- Fever 38.0°C or higher or acute illness within 7 days before intervention
- History of evolving or unstable neurologic disorder
- Unstable cardiac or respiratory status or planned cardiac transplantation
- Known allergy to immunoglobulin products or prior allergic reactions
- Prior receipt of palivizumab, other RSV antibodies, or any RSV vaccine
- Prior or planned use of monoclonal or polyclonal antibodies during the study
- Participation in another interventional study
- Children of employees or immediate family of those involved in the study
- Investigator judgment that participant or guardian unlikely to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Research Site
Hyderabad, India, 500084
Actively Recruiting
2
Research Site
Pune, India, 411006
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here