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RSV Immunogenicity Study in the Elderly (RISE)

NCT07203365 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • RSV Immunisation

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.

Sponsors & Collaborators

Principal Investigators

  • Helena Hervius Askling, Dr · Studieenheten Akademiskt Specialistcentrum

  • Christian Molnár, Dr · Familjeläkarnas Särskilda boenden

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-05-31
Completion
2029-05-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07203365 on ClinicalTrials.gov