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

NCT02600585 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 254648

Last updated 2017-10-12

No results posted yet for this study

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).

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

Recombinant Influenza Vaccine

Intramuscular injection of study vaccine

BIOLOGICAL

Inactivated Influenza Vaccine

Intramuscular injection of study vaccine

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • Protein Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Roger Baxter, MD · Kaiser Permanente

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600585 on ClinicalTrials.gov