A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease
NCT06077968 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1
Last updated 2026-05-11
Summary
The main purpose of this study is to learn about the effectiveness of Pfizer's ABRYSVO vaccine. This vaccine helps to prevent infections caused by Respiratory Syncytial Virus (RSV). RSV is a virus that can cause infections in the airways. These symptoms can be cold-like symptoms, but in some cases can lead to severe symptoms or hospitalization.
This study uses only healthcare data that are already collected from routine visits to healthcare providers. This means that participants will not be actively enrolled in the study and there are no study treatments. The study will look at data for about two years. This study will look at patient information from:
* Adults ages 60 years and older
* Adults who are eligible to receive the ABRYSVO vaccination
Substudy A:
* This study will assess the duration of protection of ABRYSVO in adults ages 60 years and older after completion of the original study.
* The substudy will look at data from subsequent RSV seasons after the first dose of ABRYSVO for about 5 years.
Substudy B:
* This study will assess vaccine effectiveness of ABRYSVO after revaccination in routine use, pending ACIP recommendation for revaccination.
* The substudy will look at data for about 2 years after revaccination.
Conditions
- Respiratory Syncytial Viruses
Interventions
- BIOLOGICAL
-
Prior standard of care receipt of Pfizer's ABRYSVO vaccine
Participants will receive Pfizer's ABRYSVO vaccine as part of standard of care. Vaccine is not administered in this study.
Sponsors & Collaborators
- collaborator OTHER
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2029-05-01
- Completion
- 2029-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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