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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694392
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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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
Influenza Pneumonia Lower Respiratory Tract Infection Acute Myocardial Infarction Congestive Heart Failure Stroke Biological: Flublok Quadrivalent Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)

Study Design
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Study Type : Observational
Actual Enrollment : 2776278 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 16, 2018
Actual Primary Completion Date : April 9, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Groups and Cohorts
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Group/Cohort 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Other Outcome Measures:
  1. Number of adults 50-64 years old with select exploratory outcomes [ Time Frame: 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:

    1. PCR-tested with an influenza-like illness (ILI) International Classification of Diseases, 10th Edition code
    2. All-cause hospitalizations
    3. All-cause mortality
    4. Cardiovascular events (e.g., acute myocardial infarction, congestive heart failure, stroke, atrial fibrillation)

  2. Outcomes 1-4 to be assessed for adults 18-64 years old [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Eligible adults aged 18-64 years will receive either Flublok Quadrivalent vaccine or a standard dose inactivated influenza vaccine in the course of routine influenza vaccination during each of the two influenza seasons of the study period at Kaiser Permanente Northern California.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694392


Locations
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United States, California
Kaiser Permanente Northern California (entire region)
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Nicola P Klein, MD, PhD Kaiser Permanente
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03694392    
Other Study ID Numbers: CN-18-3176
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data reported to Sanofi Pasteur by the Kaiser Permanente Northern California Vaccine Study Center will be deidentified and aggregated.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
influenza
vaccine effectiveness
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases