Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | November 2015 |
| End Date: | September 2016 |
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).
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.
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.
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.
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