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

March 20, 2025 updated by: Kaiser Permanente

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2776278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California (entire region)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Up to 8 months
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).
Up to 8 months
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).
Up to 8 months
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A 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 A 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
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B 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 B 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Adults 18-49 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).
Up to 8 months
Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)
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 influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)
Up to 8 months
Number of Adults 50-64 Years Old With All-Cause-Hospitalizations
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 all-cause hospitalizations
Up to 8 months
Number of Adults 50-64 Years Old With All-Cause Mortality
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 all-cause mortality
Up to 8 months
Number of Adults 18-49 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).
Up to 8 months
Number of Adults 18-49 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).
Up to 8 months
Number of Adults 18-49 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).
Up to 8 months
Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI)
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 influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)
Up to 8 months
Number of Adults 18-49 Years Old With All-Cause-Hospitalizations
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 all-cause hospitalizations
Up to 8 months
Number of Adults 18-49 Years Old With All-Cause Mortality
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 all-cause mortality
Up to 8 months
Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A 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 A 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
Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B 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 B 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi Pasteur, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicola P Klein, MD, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN-18-3176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data reported to Sanofi Pasteur by the Kaiser Permanente Northern California Vaccine Study Center will be deidentified and aggregated.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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