Real-World Effectiveness of the Adjuvanted RSVPreF3 Vaccine in Adults ≥60 Years: A Pragmatic Randomized Trial (BronquiVal)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526804-59-00

Enrollment

100000

Registered

2026-07-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory syncytial virus infection–related respiratory disease

Brief summary

The primary endpoint of the study is the first occurrence of a hospitalisation for RSV-related RD (ICD-10 code for RSV infection as primary or secondary diagnosis position OR a relevant RD in any diagnose position AND RSV infection confirmed by laboratory test (Polymerase Chain Reaction, PCR or antigen) within 10 days prior to or up to 2 days after hospital admission.

Detailed description

RSV-related LRTD hospitalisations., RSV-related MACE hospitalisations., RSV-related COPD/Asthma exacerbations hospitalisations

Interventions

DRUGArexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant

DRUGadjuvanted)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the first occurrence of a hospitalisation for RSV-related RD (ICD-10 code for RSV infection as primary or secondary diagnosis position OR a relevant RD in any diagnose position AND RSV infection confirmed by laboratory test (Polymerase Chain Reaction, PCR or antigen) within 10 days prior to or up to 2 days after hospital admission.	—

Secondary

Measure	Time frame
RSV-related LRTD hospitalisations., RSV-related MACE hospitalisations., RSV-related COPD/Asthma exacerbations hospitalisations	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 23, 2026