Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

NCT01825200 · View on ClinicalTrials.gov ↗

Study Summary

The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.

Conditions Studied

Interventions

  • BIOLOGICAL Afluria
  • BIOLOGICAL Flublok

Study Locations (14)

Texas

  • Research Across America — Dallas
  • Benchmark Research — Fort Worth
  • Benchmark Research — San Angelo

Arizona

  • Genova Clinical Research — Tucson

Florida

  • Clinical Research of South Florida — Coral Gables

Georgia

  • Meridian Clinical Research — Savannah

Kansas

  • Heartland Research Associates, LLC — Wichita

Louisiana

  • Benchmark Research — Metairie

Maine

  • Maine Research Associates, LLC — Auburn

Nebraska

  • Meridian Clinical Research — Omaha

Trial Details

FieldValue
Enrollment Target 2,640 participants
Start Date 2013-03
Est. Completion 2013-05
Phase Phase 3

Sponsor

Protein Sciences Corporation

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01825200

The ClinicalTrials.gov registry entry for NCT01825200 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,640 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protein Sciences Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions — of which Afluria is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01825200 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Texas, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01825200 about?

NCT01825200 is a clinical study titled "Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age". The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acc...

What is the current status of trial NCT01825200?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,640 participants. The study started on 2013-03. Estimated completion is 2013-05.

What conditions does trial NCT01825200 study?

This clinical trial studies the following conditions: Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01825200?

The interventions under investigation include: Afluria (BIOLOGICAL), Flublok (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01825200?

This trial is sponsored by Protein Sciences Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01825200 being conducted?

This trial has 14 study locations across Arizona, Florida, Georgia, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial