Intradermal Influenza Vaccine Study in Elders
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Influenza Vaccine (2007-2008)
Intervention description: Manufactured by Sanofi Pasteur
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; prevention; intradermal; vaccine; delivery; elderly

Summary:

      This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza
      vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre-
      and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were
      compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory, medically stable persons 65 years of age or older

          -  Able to read and understand informed consent

          -  Available during the trial period and for follow-up

          -  Able to understand and comply with planned study procedures

          -  Able to be contacted by telephone for follow-up of adverse events

        Exclusion Criteria:

          -  Known allergy to eggs or other components of vaccine (i.e., thimerosal)

          -  History of Guillain-Barré Syndrome (GBS)

          -  Has a confirmed or suspected immunodeficient or immunosuppressive condition (including
             congenital or acquired immunosuppressive therapy, and human immunodeficiency virus
             [HIV])

          -  End-stage renal disease requiring hemodialysis

          -  Active neoplastic disease or history of any hematologic malignancy (except localized
             skin or prostate cancer that is stable in the absence of therapy)

          -  Acute or chronic condition that (in the opinion of the investigator) would render
             vaccination unsafe or would interfere with the evaluation of responses (including but
             not limited to the following: known chronic liver disease, significant renal disease,
             oxygen-dependent chronic lung disease, New York Heart Association Functional Class III
             or IV, unstable or progressive neurologic disorder, insulin controlled diabetes
             mellitus)

          -  Use of experimental vaccines within the month prior to study entry, or expected use of
             experimental or licensed vaccines or blood/blood products during the duration of the
             study.

          -  Receipt of immunoglobulin or other blood product within 3 months prior to enrollment

          -  Receipt of other licensed vaccines within the preceding 4 weeks

          -  History of a severe reaction following influenza vaccination

          -  Current or planned participation in a research study of an investigational drug.
             Participation in research studies that involve use of licensed drugs, for either
             approved or investigational indications, will be permitted with the approval of the
             PI, as will participation in research studies that do not involve vaccines or
             medications.

          -  Current use or previous chronic administration, defined as >14 days during the
             previous six months, of immunosuppressants or other immune-modifying drugs. (For oral
             or injected corticosteroids, the immune-modifying dose is defined as prednisone or its
             equivalent >10 mg/day or >800mcg per day of inhaled beclomethasone dipropionate or
             equivalent ). Topical steroids are allowed.

          -  Use of cytotoxic therapy in the previous 2 years.

          -  Plans to receive cytotoxic therapy during the study period.

          -  Concurrent moderate to severe illness. Need to defer vaccination until recovery.
             (Vaccination is not contraindicated in subjects with mild illnesses or with low-grade
             fever).