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

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ClinicalTrials.gov Identifier: NCT02285998
Recruitment Status : Completed
First Posted : November 7, 2014
Results First Posted : October 4, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Flublok Quadrivalent Influenza Vaccine Biological: Inactivated Influenza Vaccine Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9003 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : October 2014
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)


  2. 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.


  3. 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.

  4. Percentage of Participants With Seroconversion [ Time Frame: Days 0 through 28 ]
    Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.

  5. 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.

  6. Number of Participants With Unsolicited Adverse Events [ Time Frame: Days 0 through 28 ]
    Unsolicited adverse events reported in the 28 days following vaccine administration.

  7. 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.


  8. Measure of Post-vaccination HAI GMTs [ Time Frame: Days 0 through 28 ]
    GMT titers for all four antigens in a preselected subset of subjects.

  9. Number of Participants With Systemic Reactogenicity [ Time Frame: Days 0 through 7 ]
    Solicited events of systemic reactogenicity reported during Day 0-7.


Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

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): NCT02285998


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Sponsors and Collaborators
Protein Sciences Corporation
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT02285998     History of Changes
Other Study ID Numbers: PSC12
First Posted: November 7, 2014    Key Record Dates
Results First Posted: October 4, 2016
Last Update Posted: October 27, 2017
Last Verified: September 2017

Keywords provided by Protein Sciences Corporation:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs