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

January 29, 2015 updated by: Protein Sciences Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704-1152
        • Genova Clinical Research
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Benchmark Research
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68164
        • Meridian Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada, LLC
    • New York
      • Binghamton, New York, United States, 13901
        • Regional Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • San Angelo, Texas, United States, 76904
        • Benchmark Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 Days
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.
7 Days
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
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Protein Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joe Blumenau, MD, Research Across America
  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSC11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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