Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years

Stroke Clinical Trial

Official title:

Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694392
• Other study ID #: CN-18-3176
• Status: Completed
• Start date: September 16, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2776278
• Est. completion date: December 31, 2022
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Congestive Heart Failure
• Heart Failure
• Infarction
• Influenza
• Influenza, Human
• Lower Respiratory Tract Infection
• Myocardial Infarction
• Pneumonia
• Respiratory Tract Infections
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California (entire region)	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adults 50-64 years old with select exploratory outcomes	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)	Up to 8 months
Other	Outcomes 1-4 to be assessed for adults 18-64 years old	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).	Up to 8 months
Primary	Number of adults 50-64 years old with polymerase-chain reaction (PCR) confirmed influenza tests	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).	Up to 8 months
Secondary	Number of adults 50-64 years old hospitalized with PCR-confirmed influenza	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).	Up to 8 months
Secondary	Number of adults 50-64 years old hospitalized with community-acquired pneumonia	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).	Up to 8 months
Secondary	Number of adults 50-64 years old hospitalized with cardio-respiratory events	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).	Up to 8 months