Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Prevention
Enrollment
110actual
Sites
7
Country
India
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-31 | actual | When the study began enrolling |
| Primary completion | 2026-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- RSV Immunization
Intervention
- Biological: Nirsevimab — also filed as 526, Beyfortus®
Primary outcomes
what the primary-completion date above is the date OFPresence of immediate adverse events (AEs)
measured Within 30 minutes after immunization
Presence of non-serious AEs
measured From Day 01 through Day 31
Presence of adverse events of special interest (AESIs) throughout the study
measured Throughout the study (approximately 6 months)
Presence of medically attended adverse events (MAAEs) throughout the study
measured Throughout the study (approximately 6 months)
Presence of serious adverse events (SAEs) throughout the study
measured Throughout the study (approximately 6 months)
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed