Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Kaiser Permanente
Conditions:
Respiratory Syncytial Viruses
Eligibility:
All Genders
60+ years
Brief 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 tha...
Detailed Description
The overall research question asks how effective ABRYSVO® is against severe RSV disease in real-world populations. The primary objective of this study is to estimate the VE of Pfizer's ABRYSVO® vaccin...
Eligibility Criteria
Inclusion
- KPSC patients eligible to receive ABRYSVO® per current 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2029
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06077968
Start Date
November 1 2023
End Date
May 1 2029
Last Update
December 18 2025
Active Locations (1)
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1
Pfizer
New York, New York, United States, 10001