At a glance
ClinicalIndex Comparison RecordPhase 4Active· 690,000 target
Drug / intervention
RSV prefusion F protein-based vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above
In Brief
A Phase 4 clinical trial evaluating RSV prefusion F protein-based vaccine for RSV. Active but no longer recruiting, targeting 690,000 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.
Study Details
Timeline
Phase 4Active
2025202620272028
First PostedNov 2024
Enrollment StartNov 2024
TodayJul 2026
Primary CompletionMay 2028
Study CompletionAug 2028
First PostedNov 12, 2024
Enrollment StartNov 18, 2024
Primary CompletionMay 1, 2028
Study CompletionAug 1, 2028
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 1.6 years agoPrimary completion in 1.8 years
Interventions
RSV prefusion F protein-based vaccinebiological
For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used