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

NCT06077968 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Observational

Started

2023-11-01

Last updated

2026-05-11

Condition(s) studied

Respiratory Syncytial Viruses

Investigational drug(s) / intervention(s)

Prior standard of care receipt of Pfizer's ABRYSVO vaccine

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. Exclusion Criteria: 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.

Primary outcome measure(s)

1. Vaccine Effectiveness (VE) calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with ABRYSVO for RSV-related hospitalized LRTD cases and controls, multiplied by 100%. — Up to 2 years
Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO against RSV-related LRTD hospitalizations
SSA Primary: To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations during the 3rd RSV season after a single dose — Up to 3 years
Among those with 3 completed RSV seasons after vaccination with a single dose of ABRYSVO®, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, using LRTD events from the 3rd season

Trial sites (1)

Facility	City	Region	Status
Pfizer	New York	New York

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06077968 on ClinicalTrials.gov ↗ ← All trials in the USA