NCT06077968

A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease

Active, enrolled Last updated 18 December 2025

What this trial tests

trial testing Prior standard of care receipt of Pfizer's ABRYSVO vaccine in Respiratory Syncytial Viruses in 1 participant. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2023

Primary endpoint
1 May 2029

1 May 2029

Quick facts

Lead sponsor	Pfizer
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1
Start date	1 November 2023
Primary completion	1 May 2029
Estimated completion	1 May 2029
Sites	1 location across United States

Drugs / interventions tested

• Prior standard of care receipt of Pfizer's ABRYSVO vaccine — full drug profile →

Conditions studied

• Respiratory Syncytial Viruses — all drugs for Respiratory Syncytial Viruses →

Sponsor

Pfizer — full company profile →

Who can join

60 and older, any sex, with Respiratory Syncytial Viruses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 3 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
   Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353