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

September 26, 2017 updated by: Protein Sciences Corporation

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.

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 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.

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.
9003

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
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center For Clinical Research
    • California
      • Redding, California, United States, 96001
        • Northern California Clinical Research Center
      • Sacramento, California, United States, 95816
        • Benchmark Research - Sacramento
      • San Francisco, California, United States, 94102
        • Benchmark Research - San Francisco
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Lynn Institute of the Rockies
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Research
    • Idaho
      • Meridian, Idaho, United States, 83642
        • ACR - Boise
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Benchmarch Research - New Orleans
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center For Pharmaceutical Research
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Meridian Research
      • Norfolk, Nebraska, United States, 68701
        • Meridian Research
      • Omaha, Nebraska, United States, 68164
        • Meridian Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Clinical Research Consortium-Nevada
    • New Hampshire
      • Newington, New Hampshire, United States, 03801
        • ActivMed Practices & Research
    • New York
      • Endwell, New York, United States, 13760
        • Regional Clinical Research, Inc.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Meridian Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Reseach
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research - Fort Worth
      • San Angelo, Texas, United States, 76904
        • Benchmark Research - San Angelo
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater

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

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Quadruple

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.
Experimental: 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
Biological: Flublok Quadrivalent Influenza Vaccine
Intramuscular injection of vaccine
Active Comparator: 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.
Biological: Inactivated Influenza Vaccine
Intramuscular injection of vaccine

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 rtPCR-confirmed Influenza-Like Illness
Time Frame: 14 days post vaccination through and up to 32 weeks post vaccination
rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination
14 days post vaccination through and up to 32 weeks post vaccination

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
Number of Participants With Culture-confirmed Influenza-Like Illness
Time Frame: 14 days post vaccination through and up to 32 weeks post vaccination

Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.

Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:

Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)
14 days post vaccination through and up to 32 weeks post vaccination
Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness
Time Frame: 14 days post vaccination through and up to 32 weeks post vaccination

Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.

CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat.
14 days post vaccination through and up to 32 weeks post vaccination
Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness
Time Frame: 14 days post vaccination through and up to 32 weeks post vaccination
rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.
14 days post vaccination through and up to 32 weeks post vaccination
Percentage of Participants With Seroconversion
Time Frame: Days 0 through 28
Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.
Days 0 through 28
Number of Participants With Local Injection Site Reactogenicity
Time Frame: Days 0 through 7
Solicited events of injection site reactogenicity reported during Day 0-7.
Days 0 through 7
Number of Participants With Unsolicited Adverse Events
Time Frame: Days 0 through 28
Unsolicited adverse events reported in the 28 days following vaccine administration.
Days 0 through 28
Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
Time Frame: Day 0 through and up to 32 weeks post vaccination

Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).

A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment.
Day 0 through and up to 32 weeks post vaccination
Measure of Post-vaccination HAI GMTs
Time Frame: Days 0 through 28
GMT titers for all four antigens in a preselected subset of subjects.
Days 0 through 28
Number of Participants With Systemic Reactogenicity
Time Frame: Days 0 through 7
Solicited events of systemic reactogenicity reported during Day 0-7.
Days 0 through 7

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

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.
October 1, 2014

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, 2015

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, 2015

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).
October 27, 2014

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.
November 4, 2014

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.
November 7, 2014

Study Record Updates

Last Update Posted (Actual)

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.
October 27, 2017

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.
September 26, 2017

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.
September 1, 2017

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.
  • PSC12

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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