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NCT02600585 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Protein Sciences Corporation.

Completed
Registry status
254,648
Enrollment target

NCT02600585: Completed study, sponsored by Protein Sciences Corporation.

NCT02600585 is a clinical trial that has completed, run by Protein Sciences Corporation. The registered enrollment target is 254,648 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02600585 has completed, sponsored by Protein Sciences Corporation.

COMPLETED
Registry status
254,648 participants
Enrollment target

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).

Primary Outcome

Incidence of Serious and/or Medically-Attended Adverse events

Interventions

  • BIOLOGICAL Inactivated Influenza Vaccine
  • BIOLOGICAL Recombinant Influenza Vaccine

Trial Details

FieldValue
Enrollment Target 254,648 participants
Start Date 2015-11
Est. Completion 2016-09
Protein Sciences Corporation

12 total trials

What the finished NCT02600585 record still lists

NCT02600585 is an observational study that tracks outcomes without assigning an intervention. Its 254,648 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 2 interventions - of which Inactivated Influenza Vaccine is the first listed.

NCT02600585 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02600585 about?

NCT02600585 is a clinical study titled "Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults". 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...

What is the current status of trial NCT02600585?

This trial is currently completed. The enrollment target is 254,648 participants. The study started on 2015-11. Estimated completion is 2016-09.

What interventions are being tested in trial NCT02600585?

The interventions under investigation include: Inactivated Influenza Vaccine (BIOLOGICAL), Recombinant Influenza Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02600585?

This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02600585, the US trial registry maintained by the National Library of Medicine. NCT02600585 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.