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

Han Tongyan

Status: Completed

Conditions: RSV Infections; Lower Respiratory Tract Infections

Treatments: Biological: Nirsevimab

Study type: Observational

Funder types: Other

Identifiers

NCT07382219

M20250653

Details and patient eligibility

About

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.

Full 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.

Enrollment: 816 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.

Exclusion criteria

1. Prior or active RSV infection.
2. Prior RSV immunization (maternal vaccine or monoclonal antibody).

Trial design

816 participants in 2 patient groups

Nirsevimab group

Description:

Infants who received Nirsevimab during the study period.

Treatment:

Biological: Nirsevimab

Control group

Description:

Infants with health records established at the same study centers during the study period who were eligible for Nirsevimab but did not receive the immunization.