Clinical trial NCT03694392: Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Pneumonia
Lower Respiratory Tract Infection
Acute Myocardial Infarction
Congestive Heart Failure
Stroke
Keywords: influenza
vaccine effectiveness
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2018-10-03
Enrollment: 2776278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
timeFrame: Up to 8 months
Secondary outcomes:
measure: Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests
timeFrame: Up to 8 months
Other outcomes:
measure: Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old With All-Cause-Hospitalizations
timeFrame: Up to 8 months
measure: Number of Adults 50-64 Years Old With All-Cause Mortality
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI)
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With All-Cause-Hospitalizations
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With All-Cause Mortality
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests
timeFrame: Up to 8 months
measure: Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests
timeFrame: Up to 8 months
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California (entire region)
state: California
Study officials:
affiliation: Kaiser Permanente
name: Nicola P Klein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsiao A, Hansen J, Nunley KV, Lewis N, Selmani A, Inamdar A, Mallett-Moore T, Izikson R, Rudin D, Klein NP. Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study. Vaccine. 2022 Jan 31;40(5):774-779. doi: 10.1016/j.vaccine.2021.12.035. Epub 2022 Jan 6.