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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06077968 on ClinicalTrials.gov