A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

• Status: Active, not recruiting
• Trial end date: 2025-04-10

Summary

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.

Study details include

• The study duration is approximately 21 months with a 2-month enrollment period.

• Study intervention is 2 doses administered 5- 6 months apart.

• The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval

• Phase: Phase 3

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Iqvia Pty Ltd