An observational study in RSV Infections and Lower Respiratory Tract Infections, sponsored by Han Tongyan. Completed at 7 sites in China. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Han Tongyan · Observational
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.
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.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's enrollment of 816 is above the median of 346 across 73 observational studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Han Tongyan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025
Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
Exclusion Criteria:
Infants who received Nirsevimab during the study period.
Biological: Nirsevimab
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.
Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants \< 5 kg and 100 mg for infants ≥ 5 kg.
Also known as: Beyfortus
Incidence of RSV-related LRTI hospitalization.
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).
Time frame: From enrollment up to 180 days.
Incidence of all-cause LRTI hospitalization.
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.
Time frame: From enrollment up to 180 days.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Syncytial Virus Infections→
Han Tongyan