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A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

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NCT07200206 · readout in 1,134 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase
Status
Recruiting
Study type
Observational
Enrollment
3,000estimated
Sites
1
Country
South Korea

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-10-02actualWhen the study began enrolling
Primary completion2029-09-26estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-09-26estimatedThe whole study's end, after follow-up
First posted2025-10-01actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-12-03actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Respiratory Syncytial Virus

Intervention

  • Biological: Nirsevimab — also filed as Beyfortus™

Primary outcomes

what the primary-completion date above is the date OF
Occurence of Adverse Events (AEs)
measured Up to 180 days post dose
Occurence of Serious Adverse Events (SAEs)
measured Up to 180 days post dose
Occurrence of AE of special interest (AESI)
measured Up to 180 days post dose
Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label
measured Up to 180 days post dose
Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
measured Up to 180 days post dose

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