Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
800actual
Sites
30
Country
China
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 | 2021-11-24 | actual | When the study began enrolling |
| Primary completion | 2025-11-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-24 | actual | The whole study's end, after follow-up |
| First posted | 2021-11-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lower Respiratory Tract Infection
Interventions
- Drug: Nirsevimab — also filed as MEDI8897
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFIncidence of medically attended LRTI due to RT-PCR-confirmed RSV
measured Day 1 to Day 151
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