Respiratory Syncytial Virus Infections Clinical Trial
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
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
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