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

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.

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Key information

Conditions

RSV Infections Infections Lower Respiratory Tract Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Inner Mongolia Maternity and Child Health Care Hospital, Hohhot, Inner Mongolia, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nirsevimab

Biological

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

Other names: Beyfortus

Primary outcomes

Incidence of RSV-related LRTI hospitalization.

Time frame: From enrollment up to 180 days.

Number of participants admitted to the hospital (inpatient care) with a diagnosis of LRTI and a laboratory-confirmed RSV infection (detected by PCR or antigen testing).

Secondary outcomes

Incidence of all-cause LRTI hospitalization.

Time frame: From enrollment up to 180 days.

Number of participants admitted to the hospital with a diagnosis of LRTI caused by any pathogen (including RSV, other viruses, or bacteria) or unspecified agents.

Sponsors and collaborators

Lead sponsor

Han Tongyan

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 2, 2026
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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