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

NCT07673081 | Not Yet Recruiting

• 1 other identifier: C3671094
• Study Type: observational
• Target: 293,334
• Locations: 0 countries
• Sites: N/A

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

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

RSV, Respiratory Syncytial Virus; Vaccine effectivness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of RSV-related outcomes

  up to 3 years

• Incidence of All-cause outcomes

  up to 3 years

Study Arms (2)

Vaccinated group

Individuals with documented receipt of an RSV vaccine in EHR data. Vaccines included: ABRYSVO® (Pfizer),AREXVY® (GSK), mRESVIA® (Moderna)

Unvaccinated comparator group:

Individuals not yet vaccinated at cohort entry, but otherwise eligible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Ividence: collaborator

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share