Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluBlok Influenza Vaccination; TIV (Fluzone) Influenza Vaccination
Intervention description: 0.5mL dose for intramuscular injection; 0.5mL dose for intramuscular injection
Intervention MeSH terms: Hemagglutinins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 602.0
Sex: All
Minimum age: 50 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      The purpose of this study was to evaluate and compare the safety, reactogenicity,
      immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent
      influenza vaccine (TIV)in healthy adults age 50-64 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 50 to 64.

          -  Females should be at least 2 years post-menopausal or sterile or practicing accepted
             form of birth control (including: condom with spermicidal, licensed hormonal
             contraceptive, abstinence, IUD or monogamous relationship with a vasectomized
             partner).

          -  Healthy, as determined by oral temperature <100.0°F, medical history, and medical
             assessment w/ brief physical evaluation by RN (if indicated) based on medical history.

          -  Able to understand and comply with planned study procedures.

          -  Provides written informed consent prior to initiation of any study procedure.

        Exclusion Criteria:

          -  Known allergy to eggs or other vaccine components.

          -  Immunosuppression as a result of an underlying illness or treatment, or used
             anticancer chemotherapy or radiation therapy within the preceding 36 months.

          -  Any malignancy other than localized prostate cancer, diagnosed or treated actively
             during the past 5 years. Exceptions: Subjects with a history of lymphoproliferative
             disorder at any time in their life will be excluded, while subjects with a history of
             localized nonmelanotic skin cancer that has been completely removed during the past 5
             years may be eligible.

          -  Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids
             (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6
             months (Nasal and topical steroids are allowed).

          -  Diagnosis of or treatment for bipolar disorder, severe major depression, schizophrenia
             or other major psychotic disorder in the past 3 months that is associated with
             severely impaired judgment or cognition.

          -  History of receiving immunoglobulin or other blood product within the 3 months prior
             to enrollment in this study.

          -  Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4
             weeks (for live vaccines) prior to enrollment in this study.

          -  Use of experimental vaccines or any influenza vaccine other than FluBlOk after May
             31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere
             epidemic seasons.

          -  History of severe reactions following immunization with influenza virus vaccines.

          -  Moderate to severe acute illness or febrile illness (oral temperature greater than
             100degreesF) within 1 week prior to vaccination.

          -  Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or
             medication) within 1 month prior to enrollment in this study, or expects to receive an
             experimental agent during study period.

          -  Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.

          -  History of alcohol or drug abuse in the last 5 years.

          -  History of Guillain-Barré Syndrome.

          -  Subject is not available for three (3) or more consecutive weeks during active
             influenza season.

          -  Any acute or chronic medical condition that, in the opinion of the investigator, would
             render vaccination unsafe, interfere with the evaluation of responses, or render the
             subject unable to meet the requirements of the protocol. These conditions include, but
             are not limited to: history of significant renal impairment (dialysis and treatment
             for kidney disease, including diabetic and hypertensive kidney disease); subjects with
             diabetes mellitus, well-controlled with oral agents may enroll as long there has been
             no dosage increase within the past 6 months; insulin-dependent diabetes is excluded;
             cardiac insufficiency, if heart failure is present (New York Heart Association
             Functional Class III or IV); an arteriosclerotic event during the 6 months prior to
             enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral
             arteries, or transient ischemic attack)