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

NCT07382219 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 816

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Han Tongyan

    lead OTHER

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382219 on ClinicalTrials.gov