About this trial
Among non-pregnant adults observed in Epic Cosmos since August 2023 who are eligible for RSV vaccination, what is the effectiveness of ABRYSVO® (RSVpreF), compared with unvaccinated individuals, in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest, within a target trial emulation (TTE) framework
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will include non-pregnant adults aged ≥18 years and ≥ 60 years in the United States with care observed in Epic Cosmos, contributing healthcare systems on or after August 2023. Individuals will be required to have sufficient healthcare engagement to ensure adequate data capture and observability within the database. Within this population, vaccinated individuals will be identified by documented administration of an RSV vaccine in structured EHR data.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization
Incidence of RSV-related Lower Respiratory Tract Disease (LRTD) hospitalization
Secondary outcomes
Incidence of RSV-related outcomes
ARI/LRTD non-inpatient encounter, ARI/LRTD severe outcome, ARI/LRTD critical outcome, CV events with different care settings, thromboembolic event with different care settings, asthma exacerbation with different care settings, COPD exacerbation with different care settings, and pneumonia with different care settings.
Incidence of All-cause outcomes
all-cause ARI/LRTD encounter with different care settings, severe outcome, critical outcome, CV events with different care settings, thromboembolic event with different care settings, asthma exacerbation with different care settings, COPD exacerbation with different care settings, pneumonia with different care settings, and dementia (new onset).
Locations
Sponsors and contacts
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Pfizer
Lead sponsor
Ividence
Collaborator
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