NCT02600585

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 254,648 (actual)
• Sponsor: Protein Sciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Influenza Vaccine	Intramuscular injection of study vaccine
BIOLOGICAL	Inactivated Influenza Vaccine	Intramuscular injection of study vaccine

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-11-09
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States