Condition: Respiratory Syncytial Virus (RSV) · Sponsor: AstraZeneca
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.
This description comes directly from the study's public registry record.
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
Always discuss trial participation with your own doctor first.
| Research Site | Hyderabad, India | Recruiting |
| Research Site | Kanpur, India | Recruiting |
| Research Site | Kolkata, India | Recruiting |
| Research Site | Mysore, India | Recruiting |
| Research Site | Pune, India | Recruiting |
| Research Site | Vidyanagar, Hubballi, India | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06851806