At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Nirsevimab for Respiratory Syncytial Virus Infections. Completed, enrolled 33 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.