Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age

Completed · Phase 3

Conditions studied: Influenza

In brief

The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.

Key facts

Study ID

NCT02285998

Run by

Protein Sciences Corporation

People needed

9003

Starts

2014-10-01

Expected to finish

2015-05-01

Last updated by the study team

2017-10-27

Who can join

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

You may qualify if…

• Ambulatory adults aged 50 and older.
• Medically stable, as determined by medical history and targeted physical examination. "Medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study.
• Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
• 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 vaccine within 180 days prior to enrollment in this study.
• Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.

Where it is running

• Coastal Clinical Research — Mobile, Alabama, United States
• Clinical Research Consortium Arizona — Tempe, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Northern California Clinical Research Center — Redding, California, United States
• Benchmark Research - Sacramento — Sacramento, California, United States
• Benchmark Research - San Francisco — San Francisco, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Meridian Research — Savannah, Georgia, United States
• ACR - Boise — Meridian, Idaho, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• Benchmarch Research - New Orleans — Metairie, Louisiana, United States
• ActivMed Practices & Research — Methuen, Massachusetts, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Meridian Research — Bellevue, Nebraska, United States
• Meridian Research — Norfolk, Nebraska, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Clinical Research Consortium-Nevada — Las Vegas, Nevada, United States
• ActivMed Practices & Research — Newington, New Hampshire, United States

Full record on ClinicalTrials.gov

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