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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01825200
Recruitment Status : Completed
First Posted : April 5, 2013
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Protein Sciences Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Flublok Biological: Afluria Phase 3

Detailed Description:
The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Flu Flu Shot

Arm Intervention/treatment
Active Comparator: 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
Biological: 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.

Placebo Comparator: 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
Biological: 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.




Primary Outcome Measures :
  1. Number of Participants With Common Hypersensitivity Reactions as Measure of Safety [ Time Frame: 30 Days ]
    Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.


Secondary Outcome Measures :
  1. Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration [ Time Frame: 30 Days ]
    Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration

  2. Number of Participants With Local and Systemic Events Reported as a Measure of Safety [ Time Frame: 7 Days ]
    Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.

  3. Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety [ Time Frame: 7 Days ]
    Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ambulatory adults aged 50 years and older
  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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825200


Locations
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United States, Arizona
Genova Clinical Research
Tucson, Arizona, United States, 85704-1152
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Maine
Maine Research Associates, LLC
Auburn, Maine, United States, 04210
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68164
United States, Nevada
Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States, 89104
United States, New York
Regional Clinical Research
Binghamton, New York, United States, 13901
United States, North Carolina
Wake Research
Raleigh, North Carolina, United States, 27612
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Benchmark Research
Fort Worth, Texas, United States, 76135
Benchmark Research
San Angelo, Texas, United States, 76904
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
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Principal Investigator: Brandon Essink, MD Meridian Clinical Research
Principal Investigator: Paul Bradley, MD Meridian Clinical Research
Principal Investigator: William Seger, MD Benchmark Research
Principal Investigator: Darrell Herrington, DO Benchmark Research
Principal Investigator: George Bauer, MD Benchmark Research
Principal Investigator: Frank Eder, MD Regional Clinical Research
Principal Investigator: Treva Tyson, MD Wake Research
Principal Investigator: Bob Weiss, MD Maine Research Associates, LLC
Principal Investigator: Jeffrey Rosen, MD Clinical Research of South Florida
Principal Investigator: Joe Blumenau, MD Research Across America
Principal Investigator: Steven Folkerth, MD Clinical Research Center of Nevada, LLC
Principal Investigator: Leah Schmidt, DO Genova Clinical Research
Principal Investigator: Eric Sheldon Miami Research Associates
Principal Investigator: Alan C. Wine, MD Rapid Medical Research, Inc.
Principal Investigator: Terry Poling, MD Heartland Research Associates, LLC

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT01825200     History of Changes
Other Study ID Numbers: PSC11
First Posted: April 5, 2013    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015
Last Verified: January 2015

Keywords provided by Protein Sciences Corporation:
Influenza

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases