Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RSV, Respiratory Syncytial Virus, Vaccine effectivness
Brief summary
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
Interventions
None listed
Sponsors
Pfizer
Ividence
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: Vaccinated Cohort Patients must meet all the following inclusion criteria to be eligible for inclusion in the vaccinated cohort: Adults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date. Have a documented administration of ABRYSVO® (or AREXVY®，mRESVIA® in the later phase) in Epic Cosmos on or after August 2023. The index date for vaccinated individuals will be defined as the date of RSV vaccination. Unvaccinated Cohort Patients must meet all the following inclusion criteria to be eligible for inclusion in the unvaccinated cohort: Adults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date. Have no documented receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date. The index date for unvaccinated individuals will be defined as the start date of each sequential trial (e.g., 1st date of each month) in which they met eligibility criteria. Exclusion: Vaccinated Cohort Patients meeting any of the following criteria will not be included in the vaccinated cohort: Individual with receipt of any RSV vaccine in Epic Cosmos prior to the trial start date, as defined above (applicable to all analyses except for the analysis of recipients of multiple doses). Non-US residents. Unvaccinated Cohort Patients meeting any of the following criteria will not be included in the unvaccinated cohort: Individual with receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date, as defined above. Non-US residents. Patients must meet all the inclusion criteria and none of the
Exclusion criteria
to meet eligibility requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization | up to 3 years |
| Incidence of RSV-related Lower Respiratory Tract Disease (LRTD) hospitalization | up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of RSV-related outcomes | up to 3 years | 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 | up to 3 years | 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). |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed