A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With IQVIA Pty Ltd.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Prevention
Enrollment
33actual
Sites
9
Country
Japan
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 | 2023-07-27 | actual | When the study began enrolling |
| Primary completion | 2025-07-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-24 | actual | The whole study's end, after follow-up |
| First posted | 2023-09-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-16 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Respiratory Syncytial Virus Infections
Intervention
- Drug: Nirsevimab — also filed as MEDI8897
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
measured From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-05-19 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-27 · 698 KB · SAP_001.pdf
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