RESPIRATORY SYNCYTIAL VIRUS, GLYCOPROTEIN F, RECOMBINANT, STABILISED IN THE PRE-FUSION CONFORMATION, ADJUVANTED WITH AS01E for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- 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.\n- Individuals who can understand and read Swedish.\n- Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine.\n- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n- Participants who are medically stable in the opinion of the investigator at the time of first vaccination.\n- 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

• {"criterion_text":"- 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.\n- 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.\n- Individuals who have already received an RSV vaccine dose at any time in the past.\n- Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial\n- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial.\n- Treatment or disease which, according to the investigator, can affect treatment or trial results.\n- Any of the following medical conditions: -\tUnstable chronic illness -\tRecurrent or un-controlled neurological disorders or seizures -\tSignificant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study -\tAny other medical condition that in the judgment of the investigator would make intramuscular injection unsafe -\tAny other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study -\tAny history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures -\tHistory 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\n- Participation in another clinical trial during the study period, or any previous clinical trials with RSV- or hMPV-vaccine or other prophylaxis.\n- Planned move during the study period that will prohibit participating in the study until study end.\n- Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to Sponsor or PI."}

Primary endpoints

• {"endpoint_text":"- To describe the neutralizing antibody titers against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants 60 65 years old and ≥80 years old.","definition_or_measurement_approach":"Measurement of neutralizing antibody titers against RSV A and B at day 31 (one month after the prime dose)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence, intensity and duration of solicited AEs in the study participants at the administration site and solicited systemic AEs with an onset during the 4-day follow-up period after each vaccination.","definition_or_measurement_approach":"Solicited local and systemic adverse events recorded with onset within a 4-day follow-up period after each vaccination; intensity and duration to be collected (diary card)."}
• {"endpoint_text":"- Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination.","definition_or_measurement_approach":"Recording incidence of unsolicited adverse events with onset within 30 days after each vaccination."}
• {"endpoint_text":"- Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months.","definition_or_measurement_approach":"Recording incidence of serious adverse events (SAEs) and potential immune-mediated diseases (pIMDs) from vaccination day through 6 months of follow-up."}
• {"endpoint_text":"- Occurrence of any fatal SAEs from day 1 up to study end.","definition_or_measurement_approach":"Recording any fatal serious adverse events from day 1 through study end."}

Methods

• Recruitment materials and advertisement text (Annonstext broschyr / Annonstext kort / Annonstext lang) — printed brochures targeted to the elderly and residents of long-term care facilities (SÄBO) in Sweden.
• Posters (Annonstext poster) — local poster campaigns at study sites and community locations in Sweden.
• Social media text (Annonstext sociala medier) — use of social media channels to reach older adult populations in Sweden.
• Study unit outreach (Studieenheten) materials — central study unit advertisement and recruitment communications in Stockholm/region; local site contacts provided.

Sweden

Earliest CTIS Part Ii Submission Date

16-06-2025

Latest Decision Or Authorization Date

01-07-2025

Processing Time Days

15

Number Of Sites

2

Number Of Participants

70

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden