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

Running, not enrolling

Conditions studied: Respiratory Syncytial Viruses

In brief

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.

Key facts

Study ID

NCT06077968

Run by

Pfizer

People needed

1

Starts

2023-11-01

Expected to finish

2029-05-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• KPSC patients eligible to receive ABRYSVO® per ACIP recommendations for adults ages 60 and older who are admitted to the hospital with ARI/LRTD, (defined using International Classification of Diseases (ICD) codes after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens.
• For secondary objectives estimating VE against ED admission, the TND will include KPSC patients eligible to receive ABRYSVO® who present to the ED with ARI/LRTD after start of study period, and who have had an RSV test, either through standard of care testing or blinded study testing of remnant respiratory specimens.
• For exploratory objectives estimating VE against RSV-related cardiac hospitalization, the TND will include KPSC patients eligible to receive ABRYSVO® who are hospitalized or present to the ED with cardiac events (defined using ICD codes) after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens.
• We will include membership requirement of 1 year prior to index date, which is defined as the date of hospitalization or ED admission (allowing 45-day administrative gap), to facilitate accurate capture of comorbid conditions.

You may not qualify if…

• Patients meeting any of the following criteria will not be included in the study:
• We will exclude patients who receive another licensed or investigational RSV vaccine prior to hospitalization or ED visit from the study population and analysis. Patients will be excluded if the index date is within certain time windows from vaccination date, outlined further in the exposure section below.
• SSA and SSB Eligibility Criteria:
• The inclusion criteria for Substudy A are described above for the Test Negative Design.

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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