Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Respiratory Syncytial Virus (RSV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Incidence of RSV-related Acute Respiratory Infection (ARI) hospitalization [Time frame: up to 3 years]
- Incidence of RSV-related Lower Respiratory Tract Disease (LRTD) hospitalization [Time frame: up to 3 years]
Secondary outcome measures (2)
- Incidence of RSV-related outcomes [Time frame: up to 3 years]
- Incidence of All-cause outcomes [Time frame: up to 3 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07673081 · C3671094