Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants
1 other identifier
observational
816
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedFirst Submitted
Initial submission to the registry
January 25, 2026
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedFebruary 3, 2026
February 1, 2026
3 months
January 25, 2026
February 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
From enrollment up to 180 days.
Secondary Outcomes (1)
Incidence of all-cause LRTI hospitalization.
From enrollment up to 180 days.
Study Arms (2)
Nirsevimab group
Infants who received Nirsevimab during the study period.
Control group
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.
Interventions
Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants \< 5 kg and 100 mg for infants ≥ 5 kg.
Eligibility Criteria
Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025
You may qualify if:
- Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
You may not qualify if:
- Prior or active RSV infection.
- Prior RSV immunization (maternal vaccine or monoclonal antibody).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Han Tongyanlead
Study Sites (7)
Inner Mongolia Maternity and Child Health Care Hospital
Hohhot, Inner Mongolia, 010000, China
Women and Children's Hospital
Qingdao, Shandong, 266000, China
Beijing Children's Hospital
Beijing, 100045, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Luhe Hospital
Beijing, 101149, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, 518000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
January 25, 2026
First Posted
February 2, 2026
Study Start
August 1, 2025
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
February 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share