Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPfizer

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

293,334 Participants
are grouped into 2 trial groups
Group A: Vaccinated group
Group B: Unvaccinated comparator group:

Trial outcomes

Primary outcomes

1

Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization

Time frame
up to 3 years
2

Incidence of RSV-related Lower Respiratory Tract Disease (LRTD) hospitalization

Time frame
up to 3 years

Secondary outcomes

1

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.

Time frame
up to 3 years
2

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).

Time frame
up to 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Ividence

Collaborator

This trial is not recruiting at the moment. You can still explore other options: