Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Flublok Recipients Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine. |
Biological: Flublok Quadrivalent
Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.
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| SD-IIV Recipients Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV). |
Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)
For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.
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Outcome Measures
Primary Outcome Measures
- Number of adults 50-64 years old with polymerase-chain reaction (PCR) confirmed influenza tests [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 Outcome Measures
- Number of adults 50-64 years old hospitalized with PCR-confirmed influenza [Up to 8 months]
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and 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).
- Number of adults 50-64 years old hospitalized with community-acquired pneumonia [Up to 8 months]
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
- Number of adults 50-64 years old hospitalized with cardio-respiratory events [Up to 8 months]
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Other Outcome Measures
- Number of adults 50-64 years old with select exploratory outcomes [Up to 8 months]
Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for: PCR-tested with an influenza-like illness (ILI) International Classification of Diseases, 10th Edition code All-cause hospitalizations All-cause mortality Cardiovascular events (e.g., acute myocardial infarction, congestive heart failure, stroke, atrial fibrillation)
- Outcomes 1-4 to be assessed for adults 18-64 years old [Up to 8 months]
Patients who receive either Flublok or SD-IIV will be retroactively assessed for outcomes 1-4 described (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between the ages of ≥18 and <65 years at the time of influenza vaccination
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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:
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Children <18 years old
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Adults ≥65 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Northern California (entire region) | Oakland | California | United States | 94612 |
Sponsors and Collaborators
- Kaiser Permanente
- Sanofi Pasteur, a Sanofi Company
Investigators
- Principal Investigator: Nicola P Klein, MD, PhD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CN-18-3176