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

NCT03694392 | Completed Results FDA Drug

• 1 other identifier: CN-18-3176
• Study Type: observational
• Target: 2,776,278
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Pneumonia; Lower Respiratory Tract Infection; Acute Myocardial Infarction; Congestive Heart Failure; Stroke

Keywords

influenza; vaccine effectiveness

Outcome Measures

Primary Outcomes (1)

• Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests

  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 Outcomes (5)

• Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza

  Up to 8 months

• Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia

  Up to 8 months

• Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events

  Up to 8 months

• Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests

  Up to 8 months

• Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests

  Up to 8 months

Other Outcomes (12)

• Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia

  Up to 8 months

• Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)

  Up to 8 months

• Number of Adults 50-64 Years Old With All-Cause-Hospitalizations

  Up to 8 months

Study Arms (2)

Flublok Recipients

Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.

Biological: Flublok Quadrivalent

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)

Interventions

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.

Flublok Recipients

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.

SD-IIV Recipients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Children \<18 years old
• Adults ≥65 years old

Sponsors & Collaborators

• Kaiser Permanente: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Kaiser Permanente Northern California (entire region)

Oakland, California, 94612, United States

Location

Related Publications (3)

• Hsiao A, Yee A, Izikson R, Fireman B, Hansen J, Lewis N, Gandhi-Banga S, Selmani A, Talanova O, Kabler H, Inamdar A, Klein NP. Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. AJOG Glob Rep. 2024 Sep 20;4(4):100395. doi: 10.1016/j.xagr.2024.100395. eCollection 2024 Nov.

  PMID: 39512761 DERIVED

• Hsiao A, Yee A, Fireman B, Hansen J, Lewis N, Klein NP. Recombinant or Standard-Dose Influenza Vaccine in Adults under 65 Years of Age. N Engl J Med. 2023 Dec 14;389(24):2245-2255. doi: 10.1056/NEJMoa2302099.

  PMID: 38091531 DERIVED

• 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.

  PMID: 34998605 DERIVED

MeSH Terms

Conditions

Influenza, Human; Pneumonia; Heart Failure; Stroke

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Results Point of Contact

• Title: Amber Hsiao Hyman, Senior Research Project Manger
• Organization: Kaiser Permanente Vaccine Study Center

Amber.Hyman@kp.org

510-267-7517

Study Officials

• Nicola P Klein, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 3, 2018
• Study Start: September 16, 2018
• Primary Completion: April 9, 2021
• Study Completion: December 31, 2022
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)