Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 2,776,278
- Locations
- 1
- Primary Endpoint
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
Study Overview
Brief Summary
The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Between the ages of ≥18 and <65 years at the time of influenza vaccination
- •Receive either Flublok Quadrivalent vaccine or standard dose inactivated influenza vaccine at a Kaiser Permanente Northern California facility during the study period from August 2018 through April 2020
Exclusion Criteria
- •Children <18 years old
- •Adults ≥65 years old
Arms & Interventions
Flublok Recipients
Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.
Intervention: Flublok Quadrivalent (Biological)
SD-IIV Recipients
Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).
Intervention: Standard Dose Inactivated Influenza Vaccine (SD-IIV) (Biological)
Outcomes
Primary Outcomes
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
Time Frame: Up to 8 months
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Secondary Outcomes
- Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza(Up to 8 months)
- Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia(Up to 8 months)
- Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events(Up to 8 months)
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests(Up to 8 months)
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests(Up to 8 months)