Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
NCT ID: NCT01825200
Last Updated: 2015-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2640 participants
INTERVENTIONAL
2013-03-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Flublok
Flublok containing 3x45µg (135µg total) of recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL
Flublok
A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
Afluria
Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5 mL
Afluria
Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Interventions
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Flublok
A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
Afluria
Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
Eligibility Criteria
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Inclusion Criteria
2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
3. Able to understand and comply with planned study procedures
4. Provides written informed consent prior to initiation of any study procedure.
Exclusion Criteria
2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
3. Receipt of any new medication within 30 days prior to enrollment in this study
4. Plans to participate in any investigation involving an investigational product during this study.
5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
6. 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.
50 Years
ALL
Yes
Sponsors
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Protein Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Brandon Essink, MD
Role: PRINCIPAL_INVESTIGATOR
Meridian Clinical Research
Paul Bradley, MD
Role: PRINCIPAL_INVESTIGATOR
Meridian Clinical Research
William Seger, MD
Role: PRINCIPAL_INVESTIGATOR
Benchmark Research
Darrell Herrington, DO
Role: PRINCIPAL_INVESTIGATOR
Benchmark Research
George Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
Benchmark Research
Frank Eder, MD
Role: PRINCIPAL_INVESTIGATOR
Regional Clinical Research
Treva Tyson, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Research
Bob Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Maine Research Associates, LLC
Jeffrey Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research of South Florida
Joe Blumenau, MD
Role: PRINCIPAL_INVESTIGATOR
Research Across America
Steven Folkerth, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center of Nevada, LLC
Leah Schmidt, DO
Role: PRINCIPAL_INVESTIGATOR
Genova Clinical Research
Eric Sheldon
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Alan C. Wine, MD
Role: PRINCIPAL_INVESTIGATOR
Rapid Medical Research, Inc.
Terry Poling, MD
Role: PRINCIPAL_INVESTIGATOR
Heartland Research Associates, LLC
Locations
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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
Countries
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References
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Izikson R, Leffell DJ, Bock SA, Patriarca PA, Post P, Dunkle LM, Cox MM. Randomized comparison of the safety of Flublok((R)) versus licensed inactivated influenza vaccine in healthy, medically stable adults >/= 50 years of age. Vaccine. 2015 Nov 27;33(48):6622-8. doi: 10.1016/j.vaccine.2015.10.097. Epub 2015 Nov 1.
Related Links
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Related Info
Other Identifiers
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PSC11
Identifier Type: -
Identifier Source: org_study_id
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