Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults

Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults 18 Years of Age and Older

The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).

Study Overview

• Status: Completed
• Conditions: Human Influenza
• Intervention / Treatment: Biological: Recombinant Influenza Vaccine; Biological: Inactivated Influenza Vaccine

Detailed Description

The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.

• Study Type: Observational
• Enrollment (Actual): 254648

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Vaccine Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will include adults 18 years of age and older who are vaccinated with either Flublok or IIV within the same time period, e.g. month of the year.

Description

Inclusion Criteria:

Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.

Exclusion Criteria:

Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Flublok; Recombinant influenza vaccine (RIV); Intramuscular injection of vaccine of recombinant uncleaved hemagglutinin (rHA0) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL.	Biological: Recombinant Influenza Vaccine; Intramuscular injection of study vaccine; Other Names: Flublok
Inactivated Influenza Vaccine; Injectable, inactivated, egg-based influenza vaccines (IIV); Intramuscular injection of vaccine (whether trivalent or quadrivalent) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL.	Biological: Inactivated Influenza Vaccine; Intramuscular injection of study vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)	Incidence of Serious and/or Medically-Attended Adverse events	Five months post-vaccination

Collaborators and Investigators

• Sponsor: Protein Sciences Corporation
• Collaborators: Kaiser Permanente
• Investigators: Principal Investigator: Roger Baxter, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PSC13