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NCT02600585 Clinical Trial

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

Human Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02600585
Other study ID # PSC13
Secondary ID
Status Completed
Phase N/A
First received November 5, 2015
Last updated October 11, 2017
Start date November 2015
Est. completion date September 2016

Study information
Verified date October 2017
Source Protein Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 254648
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Recombinant Influenza Vaccine
Intramuscular injection of study vaccine
• Inactivated Influenza Vaccine
Intramuscular injection of study vaccine

Locations
Country Name City State
United States Kaiser Permanente Vaccine Study Center Oakland California

Sponsors (2)
Lead Sponsor Collaborator
Protein Sciences Corporation Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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