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

NCT ID: NCT02600585

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254648 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Human Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Recombinant Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection of study vaccine

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.

Inactivated Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular injection of study vaccine

Interventions

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Recombinant Influenza Vaccine

Intramuscular injection of study vaccine

Intervention Type BIOLOGICAL

Inactivated Influenza Vaccine

Intramuscular injection of study vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Flublok

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Protein Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Baxter, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Vaccine Study Center

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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PSC13

Identifier Type: -

Identifier Source: org_study_id