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

Completed · Phase 3

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01825200

Run by

Protein Sciences Corporation

People needed

2640

Starts

2013-03-01

Expected to finish

2013-05-01

Last updated by the study team

2015-02-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ambulatory adults aged 50 years and older
• Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
• Able to understand and comply with planned study procedures
• Provides written informed consent prior to initiation of any study procedure.

You may not qualify if…

• Known contraindication to either study vaccine (see product package inserts)
• Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
• Receipt of any new medication within 30 days prior to enrollment in this study
• Plans to participate in any investigation involving an investigational product during this study.
• Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
• Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.

Where it is running

• Genova Clinical Research — Tucson, Arizona, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Benchmark Research — Metairie, Louisiana, United States
• Maine Research Associates, LLC — Auburn, Maine, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Clinical Research Center of Nevada, LLC — Las Vegas, Nevada, United States
• Regional Clinical Research — Binghamton, New York, United States
• Wake Research — Raleigh, North Carolina, United States
• Rapid Medical Research, Inc. — Cleveland, Ohio, United States
• Research Across America — Dallas, Texas, United States
• Benchmark Research — Fort Worth, Texas, United States
• Benchmark Research — San Angelo, Texas, United States

Full record on ClinicalTrials.gov

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