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

Protein Sciences Corporation254,648 enrolled

Overview

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).

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

254,648

Conditions

Human Influenza

Interventions

Recombinant Influenza VaccineBIOLOGICAL

Intramuscular injection of study vaccine

Inactivated Influenza VaccineBIOLOGICAL

Intramuscular injection of study vaccine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kaiser Permanente Vaccine Study Center

Oakland, California, United States

Outcomes

Primary Outcomes

Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)

Incidence of Serious and/or Medically-Attended Adverse events

Time frame: Five months post-vaccination

Data from ClinicalTrials.gov

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