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Completed

NCT Number: NCT03694392

Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 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.

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Key information

Conditions

Influenza Acute Myocardial Infarction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congestive Heart Failure Heart Diseases Heart Failure Infections Influenza, Human Lower Respiratory Tract Infection Lung Diseases Nervous System Diseases Orthomyxoviridae Infections Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California (entire region)

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flublok Quadrivalent

Biological

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)

Biological

For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.

Primary outcomes

  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 outcomes

  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).

  4. 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).

  5. 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).

Other outcomes

  1. 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).

  2. 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)

  3. 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

  4. 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

  5. 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).

  6. 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).

  7. 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).

  8. 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)

  9. 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

  10. 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

  11. 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).

  12. 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).

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 3, 2018
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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