RSV Immunogenicity Study in the Elderly (RISE) (NCT07203365) | Clinical Trial Compass
RecruitingPhase 3
RSV Immunogenicity Study in the Elderly (RISE)
Sweden65 participantsStarted 2025-08-25
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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Inclusion Criteria:
* Male or female individuals who were born between 1965 and 1960 or 1945 and before, at the time of the first vaccination, who live in the community or in a long-term care facility.
* Individuals who can understand and read Swedish.
* Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine.
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Participants who are medically stable in the opinion of the investigator at the time of first vaccination.
* Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate if considered by the investigator as medically stable.
Exclusion Criteria:
* Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, using immunosuppressive drugs for treatment of cancer and who have inflammatory mediated or autoimmune conditions, as judged by the Investigator.
* Individuals who have already received an RSV vaccine dose at any time in the past.
* Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial.
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning…