NCT05110261

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China

Detailed description

This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants \> 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight \< 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, \> 3 to ≤ 6 months, \> 6 months), and by GA (\< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants \> 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.

Conditions

• Lower Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Nirsevimab	Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight \< 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only.
DRUG	Placebo	Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight \<5 kg) or 1.0 mL (if weight \>=5 kg)

Timeline

• Start date: 2021-11-24
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2021-11-05
• Last updated: 2026-03-30

Locations

30 sites across 1 country: China