Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
NCT ID: NCT02285998
Last Updated: 2017-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
9003 participants
INTERVENTIONAL
2014-10-31
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL
Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine
Inactivated Influenza Vaccine
Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.
Inactivated Influenza Vaccine
Intramuscular injection of vaccine
Interventions
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Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine
Inactivated Influenza Vaccine
Intramuscular injection of vaccine
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
Yes
Sponsors
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Protein Sciences Corporation
INDUSTRY
Responsible Party
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Locations
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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
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Wake Research
Raleigh, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Meridian Research
Dakota Dunes, South Dakota, United States
Clinical Research Associates
Nashville, Tennessee, United States
Benchmark Reseach
Austin, Texas, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, United States
Benchmark Research - San Angelo
San Angelo, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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References
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Dunkle LM, Izikson R, Patriarca P, Goldenthal KL, Muse D, Callahan J, Cox MMJ; PSC12 Study Team. Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older. N Engl J Med. 2017 Jun 22;376(25):2427-2436. doi: 10.1056/NEJMoa1608862.
Other Identifiers
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PSC12
Identifier Type: -
Identifier Source: org_study_id