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RECRUITING
NCT07203365
PHASE3

RSV Immunogenicity Study in the Elderly (RISE)

Sponsor: Karin Karin Loré

View on ClinicalTrials.gov

Summary

Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections leading to hospitalizations in infants and in elderly. Arexvy is an approved vaccine for the prevention of RSV infection, however, data on its efficacy in individuals aged 80 years and older remain limited. This study aims to evaluate potential differences in immune responses to Arexvy vaccination between adults aged ≥80 years and those aged 60-65 years.

Official title: Immunogenicity After a Prime Dose and Revaccination With Adjuvanted RSVPreF3 Vaccine in the Most Elderly and Frail Population - an Open-labeled Phase IIIb-trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2025-08-25

Completion Date

2029-05-31

Last Updated

2025-10-02

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65

The RSV vaccine (Arexvy) has demonstrated efficacy against LRTD over three RSV seasons in individuals aged 60 and older, with an acceptable safety and reactogenicity profile. However, data on vaccine responses in individuals aged 80 and older, including frail individuals, remains limited. This population is particularly affected by severe RSV infections, highlighting the need for further investigation to address these gaps.

Locations (2)

Familjeläkarna SÄBO

Saltsjöbaden, Sweden

Akademiskt specialistcentrum Studieenheten

Stockholm, Sweden