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Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01825200

Public ClinicalTrials.gov record NCT01825200. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01825200
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Protein Sciences Corporation
Industry
Enrollment
2,640 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2013
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013
Last update posted
Feb 17, 2015

2013

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Genova Clinical Research Tucson Arizona 85704-1152
Clinical Research of South Florida Coral Gables Florida 33134
Meridian Clinical Research Savannah Georgia 31406
Heartland Research Associates, LLC Wichita Kansas 67207
Benchmark Research Metairie Louisiana 70006
Maine Research Associates, LLC Auburn Maine 04210
Meridian Clinical Research Omaha Nebraska 68164
Clinical Research Center of Nevada, LLC Las Vegas Nevada 89104
Regional Clinical Research Binghamton New York 13901
Wake Research Raleigh North Carolina 27612
Rapid Medical Research, Inc. Cleveland Ohio 44122
Research Across America Dallas Texas 75234
Benchmark Research Fort Worth Texas 76135
Benchmark Research San Angelo Texas 76904

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01825200, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 17, 2015 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01825200 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →