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InfluenzaPhase 3NCT02285998

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

A Phase 3 study testing Flublok Quadrivalent Influenza Vaccine and Inactivated Influenza Vaccine in people with Influenza, run by Protein Sciences Corporation at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Flublok Quadrivalent Influenza Vaccine and Inactivated Influenza Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,003 participants
Where
38 sitesUnited States
Study dates
Oct 2014to May 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ambulatory adults aged 50 and older.
  • 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.
  • Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
  • Able to understand and comply with planned study procedures.
  • Provides written informed consent prior to initiation of any study procedure.

Who cannot join

  • Known contraindication to either study vaccine (see product package inserts)
  • Receipt of any other influenza vaccine within 180 days prior to enrollment in this study.
  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Benchmark Reseach

    Austin, Texas, 78705

  • Meridian Research

    Bellevue, Nebraska, 68005

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Meridian Research

    Dakota Dunes, South Dakota, 57049

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Benchmark Research - Fort Worth

    Fort Worth, Texas, 76135

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Clinical Research Consortium-Nevada

    Las Vegas, Nevada, 89119

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • ACR - Boise

    Meridian, Idaho, 83642

  • Benchmarch Research - New Orleans

    Metairie, Louisiana, 70006

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • Clinical Research Consulting

    Milford, Connecticut, 06460

  • Coastal Clinical Research

    Mobile, Alabama, 36608

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • ActivMed Practices & Research

    Newington, New Hampshire, 03801

  • Meridian Research

    Norfolk, Nebraska, 68701

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research

    Omaha, Nebraska, 68164

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Wake Research

    Raleigh, North Carolina, 27612

  • Northern California Clinical Research Center

    Redding, California, 96001

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Benchmark Research - Sacramento

    Sacramento, California, 95816

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Benchmark Research - San Angelo

    San Angelo, Texas, 76904

  • Benchmark Research - San Francisco

    San Francisco, California, 94102

  • Meridian Research

    Savannah, Georgia, 31406

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Influenza
Being tested
Flublok Quadrivalent Influenza Vaccine, Inactivated Influenza Vaccine
Keywords
Influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flublok Quadrivalent Influenza VaccineBiological

    Intramuscular injection of vaccine

  • Inactivated Influenza VaccineBiological

    Intramuscular injection of vaccine

Study groups in NCT02285998
Study groupRoleWhat they receive
Flublok Quadrivalent Influenza VaccineExperimentalIntramuscular 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
Receives: Biological: Flublok Quadrivalent Influenza Vaccine
Inactivated Influenza VaccineActive comparatorIntramuscular 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.
Receives: Biological: Inactivated Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With rtPCR-confirmed Influenza-Like Illness

    rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination

    Measured: 14 days post vaccination through and up to 32 weeks post vaccination

Secondary outcomes (9)

  1. Number of Participants With Culture-confirmed Influenza-Like Illness

    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)

    Measured: 14 days post vaccination through and up to 32 weeks post vaccination

  2. Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness

    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.

    Measured: 14 days post vaccination through and up to 32 weeks post vaccination

  3. Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness

    rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.

    Measured: 14 days post vaccination through and up to 32 weeks post vaccination

  4. Percentage of Participants With Seroconversion

    Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.

    Measured: Days 0 through 28

  5. Number of Participants With Local Injection Site Reactogenicity

    Solicited events of injection site reactogenicity reported during Day 0-7.

    Measured: Days 0 through 7

  6. Number of Participants With Unsolicited Adverse Events

    Unsolicited adverse events reported in the 28 days following vaccine administration.

    Measured: Days 0 through 28

  7. Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)

    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.

    Measured: Day 0 through and up to 32 weeks post vaccination

  8. Measure of Post-vaccination HAI GMTs

    GMT titers for all four antigens in a preselected subset of subjects.

    Measured: Days 0 through 28

  9. Number of Participants With Systemic Reactogenicity

    Solicited events of systemic reactogenicity reported during Day 0-7.

    Measured: Days 0 through 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285998
Sponsor's protocol ID
PSC12
Status last verified
Sep 2017
First submitted
27 Oct 2014
Last updated
27 Oct 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 28636855

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flublok Quadrivalent Influenza Vaccine and Inactivated Influenza Vaccine in people with Influenza, run by Protein Sciences Corporation at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With rtPCR-confirmed Influenza-Like Illness (time frame: 14 days post vaccination through and up to 32 weeks post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.

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