NCT06042049

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	Nirsevimab	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.

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-07-24
• Completion: 2025-07-24
• First posted: 2023-09-18
• Last updated: 2026-04-16
• Results posted: 2026-04-16

Locations

9 sites across 1 country: Japan