Evaluating a new RSV vaccine for older adults
A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above
This study is testing a new RSV vaccine to see if it can help prevent hospital visits for respiratory issues in older adults aged 60 and above.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 690000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT06684743 on ClinicalTrials.gov |
What this trial studies
This pragmatic randomized trial aims to assess the effectiveness of a bivalent RSV prefusion F vaccine in preventing hospitalizations due to RSV in older adults. Participants aged 60 and above will be randomly assigned to receive either the RSV vaccine or no vaccine at all. The study will utilize Danish nationwide health registries for comprehensive data collection, including baseline information and safety monitoring. A total of 130,000 participants will be enrolled to evaluate the vaccine's impact on RSV-related and all-cause cardio-respiratory outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 years and older who can provide informed consent.
Not a fit: Patients younger than 60 years or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce hospitalizations and improve health outcomes for older adults at risk of RSV.
How similar studies have performed: Other studies have shown promise in vaccine effectiveness against RSV, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age 18 years and above * Informed consent form has been signed and dated Exclusion Criteria: * There are no specific exclusion criteria for this study
Where this trial is running
Copenhagen and 2 other locations
- Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte — Copenhagen, Denmark (Not_yet_recruiting)
- Danske Lægers Vaccinations Service — Søborg, Denmark (Recruiting)
- General Public Health Directorate of Galician Health Service — Santiago de Compostela, A Coruña, Spain (Recruiting)
Study contacts
- Study coordinator: Mats H Lassen, MD
- Email: mats.christian.hoejbjerg.lassen@regionh.dk
- Phone: +4529806779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.