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Clinical trial

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

NCT07109297 is registered in ClinicalTrials.gov with Sanofi as lead sponsor.

NCT NCT07109297
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Sanofi
Phase
Phase 4
Overall status
Active, not recruiting
Start date
July 31, 2025
Completion date
June 30, 2026
Enrollment
110 (actual)
Sites
7

Conditions

As the registry lists them; a condition with its own page is linked.

rsv immunization