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

Respiratory Syncytial Viruses Clinical Trial

Official title: Retrospective Study Evaluating ABRYSVO Vaccine Effectiveness Against Severe Lower Respiratory Tract Infection in Older Adults

Status Recruiting

Clinical Trial 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

• Are eligible to receive the ABRYSVO vaccination

Clinical Trial Description

The primary objective of this retrospective study is to estimate vaccine effectiveness of Pfizer's ABRYSVO vaccine against RSV-related lower respiratory tract infection requiring hospitalization among Kaiser Permanente Southern California members who are eligible for vaccination per current recommendations from the Advisory Committee on Immunization Practices (ACIP). Analyses will employ a retrospective case-control study with test negative design (TND) and a retrospective cohort design. The TND will assess RSV-related outcomes, while the cohort design will assess all-cause outcomes. The cohort study may also assess RSV-related outcomes. Standard of care (SOC) RSV testing and re-testing of remnant SOC respiratory specimens for those who did not have SOC testing will be used to define RSV-related endpoints. For the cohort design, a sensitivity analysis including imputation of results for individuals experiencing lower respiratory tract infections without confirmation of RSV positivity or negativity may also be conducted. In the event that standard of care testing practices decline or there are not enough available specimens for estimating RSV-associated VE, the study may be extended to additional seasons. Secondary objectives of the TND, and if conducted for RSV-related endpoints, of the cohort study, include estimating vaccine effectiveness against: RSV-related lower respiratory tract infection hospitalizations among high-risk groups, RSV-related acute respiratory tract infection hospitalizations, and Emergency Department (ED) visits. The retrospective cohort analysis will provide VE estimates against additional all-cause ARI and LRTI outcomes, as well as incidence rates and rate reductions for study outcomes, and will include outpatient outcomes. Analyses will include stratifications by presence of comorbidity, RSV subgroup, severity, age, frailty, and other selected demographic factors. ;

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Viruses
• Respiratory Tract Infections

• NCT number: NCT06077968
• Study type: Observational
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Status: Recruiting
• Start date: November 1, 2023
• Completion date: December 31, 2025