Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
brief summary
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
detailed description
Study duration: up to 16 months, including 10 months of enrollment and 6 months of follow-up
* Treatment duration: 1 day; 1 intramuscular (IM) injection * Visit frequency:
* 1 in-person visit for immunization (Visit \[V\] 01) at Day (D) 1. * 3 phone call visits (V2, V3 and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181 (+14 days) respectively.
official title
A Phase 4, Open-label, Single-arm Clinical Study to Describe Safety and Efficacy Outcomes Associated With the Use of Nirsevimab in Neonates and Infants Born During or Entering Their First Respiratory Syncytial Virus (RSV) Season and in Children up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season