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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:10/29/2017
Start Date:October 2014
End Date:May 2015

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Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age

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.

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. Real-time Polymerase Chain Reaction (rtPCR) will be used to confirm influenza
infection and to type the strains involved, as molecular methodologies have been demonstrated
to be more sensitive than other more traditional methodologies, e.g. culture. For
rtPCR-positive clinical samples, reserved aliquots will be processed for culture, so that
antigenic similarity to the HA present in study vaccines can be tested.

In various clinical studies the investigators demonstrated that the immune response against
the influenza A viruses is improved as a result of the higher hemagglutinin content.
Furthermore, influenza virus disease and hospitalization associated with influenza-related
illness in older adults (> 50 years) was considerably reduced (90%) following vaccination
with TIV, even though the circulating influenza A strain was antigenically dissimilar to that
in the vaccine. However, more recently Skowronski et al. reported that the low influenza
vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead
related to mutations in the egg-adapted H3N2 vaccine strain. Flublok manufactured using
recombinant technology does not contain the mutations responsible for the reported lower
effectiveness and may thus offer improved protection when mutations such as those described
are induced in the process of adapting the influenza virus to growth in eggs.

Inclusion Criteria:

1. Ambulatory adults aged 50 and older.

2. 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.

3. Absence of underlying conditions that make participation in the study contrary to the
subject's best interest.

4. Able to understand and comply with planned study procedures.

5. Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

1. Known contraindication to either study vaccine (see product package inserts)

2. Receipt of any other influenza vaccine within 180 days prior to enrollment in this
study.

3. 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.
We found this trial at
38
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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Milford, CT
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
2336
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Austin, Texas 78705
1212
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Bellevue, Nebraska 68005
1301
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Cleveland, Ohio 44122
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Colorado Springs, Colorado 80907
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801 Monterey Street
Coral Gables, Florida 33134
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Dakota Dunes, South Dakota 57049
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Endwell, New York 13760
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Fort Worth, Texas 76135
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Jacksonville, Florida 32205
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Kansas City, Missouri 64114
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Las Vegas, Nevada 89119
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Lexington, Kentucky 40509
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Little Rock, Arkansas 72205
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Meridian, Idaho 83642
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Metairie, Louisiana 70006
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Methuen, Massachusetts 01844
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Mobile, Alabama 36608
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Nashville, Tennessee 37203
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Newington, New Hampshire
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Norfolk, Nebraska 68701
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Norman, Oklahoma 73069
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Omaha, Nebraska 68134
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Port Orange, Florida 32127
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Raleigh, North Carolina 27612
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Rochester, New York 14609
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Sacramento, California 95822
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