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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

September 16, 2018

Estimated Primary Completion Date

May 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Number of adults 50-64 years old hospitalized with PCR-confirmed influenza[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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).

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 and 2019-2020 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.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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.
Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)
For the 2018-2019 flu season, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent. The SD-IIV for the 2019-2020 flu season will be determined prior to the start of the season.

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1600000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 31, 2021

Estimated Primary Completion Date

May 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Kaiser Permanente

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nicola P Klein, MD, PhD Kaiser Permanente

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名