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

Kaiser Permanente

Status: Completed

Conditions: Stroke; Influenza; Lower Respiratory Tract Infection; Pneumonia; Acute Myocardial Infarction; Congestive Heart Failure

Treatments: Biological: Flublok Quadrivalent; Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03694392

CN-18-3176

Details and patient eligibility

About

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.

Enrollment: 2,776,278 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,776,278 participants in 2 patient groups

Flublok Recipients

Description:

Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.

Treatment:

Biological: Flublok Quadrivalent

SD-IIV Recipients

Description:

Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).

Treatment:

Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)