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New treatment option for RSV Immunisation
Official title RSV Immunogenicity Study in the Elderly (RISE)
ClinicalTrials.gov ID: NCT07203365
What this study is testing
What is This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65?
This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65 is an investigational medicine, being studied as a potential treatment for rsv immunisation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease...
- 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 of participation in the trial.
- Treatment or disease which, according to the investigator, can affect treatment or trial results.
- Any of the following medical conditions: Unstable chronic illness, Recurrent or un-controlled neurological disorders or seizures, Significant...
See the full eligibility 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.
- 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...
- 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 of participation in the trial.
- Treatment or disease which, according to the investigator, can affect treatment or trial results.
- Any of the following medical conditions: Unstable chronic illness, Recurrent or un-controlled neurological disorders or seizures, Significant underlying illness that in the opinion of the investigator would be expected...
- Participation in another clinical trial during the study period, or any previous clinical trials with RSV- or hMPV-vaccine or other prophylaxis.
- Planned move during the study period that will prohibit participating in the study until study end.
- Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to Sponsor or PI.
- Co-administration of other vaccines less than 14 days before or after study vaccination. A period of less than 30 days before or after study vaccination applies in the case of Shingrix.
The study team makes the final eligibility decision.
Where it's taking place
- Saltsjöbaden, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saltsjöbaden, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.