BridgeMD
RISE
EU CTIS ID: 2024-520141-23-01
What this study is testing
To describe the induction of neutralizing antibodies against RSV A and B following the first dose of Arexvy in older adults aged 80 years and older and those aged 60 to 65 years.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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.
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 (GVHD), solid-organ transplanted, other immunosuppressive drugs for treatment of cancer and inflammatory mediated or autoimmune conditions, as judged by the Investigator.
- 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.
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, other immunosuppressive drugs for treatment of cancer and inflammatory mediated or autoimmune conditions, as judged by the Investigator.
- 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.
- 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 to prevent completion of the study - Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe - Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study - Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures - History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures
- 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.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.