NCT07382219

Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants

Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants: A Multicenter Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 816 (actual)
• Sponsor: Han Tongyan · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

Summary

A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Clinical records will be used to compare outcomes between infants who received Nirsevimab and a control group. The study focuses on infants aged 0 to 1 year during the RSV season.

Detailed description

The purpose of this study is to evaluate the effectiveness of Nirsevimab in preventing RSV-related and all-cause lower respiratory tract infections (LRTI) among infants in a real-world setting. The target population includes infants aged 0 to 1 year enrolled across seven Chinese tertiary hospitals during the RSV season (September 2024 through April 2025). The study employs a target trial emulation design to compare infants receiving Nirsevimab with a control group of infants who did not receive Nirsevimab. Outcomes will be assessed over a follow-up period of up to 180 days. Researchers will utilize hospital electronic medical records to identify the incidence of infections, hospitalizations, and admissions to the intensive care unit (ICU). Statistical methods, such as inverse probability of treatment weighting, will be applied to balance the characteristics of the two groups and ensure a valid comparison.

Conditions

• RSV Infections
• Lower Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	Nirsevimab	Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants \< 5 kg and 100 mg for infants ≥ 5 kg.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2026-02-02
• Last updated: 2026-02-03

Locations

7 sites across 1 country: China

Regulatory

• FDA-regulated drug study