clinical trial · NCT06042049
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
AstraZeneca·phase3·completed·n = 33
Respiratory Syncytial Virus InfectionsNirsevimab
brief 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.
started
Jul 27, 2023
primary completion
Jul 24, 2025
completion
Jul 24, 2025
last updated
Apr 16, 2026
official title
A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in Japan
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol