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

Completed

Conditions studied: Human Influenza

In brief

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).

Key facts

Study ID

NCT02600585

Run by

Protein Sciences Corporation

People needed

254648

Starts

2015-11-01

Expected to finish

2016-09-01

Last updated by the study team

2017-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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