B-cell Immunity to Influenza (SLVP017)- Year 1, 2009
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® 2009-2010 Formula; FluMist® 2009-2010 Formula
Intervention description: This vaccine is given intramuscularly; This vaccine is given intranasally
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 8 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Child identical twins; Young and elderly adults

Summary:

      This is an exploratory study using a strategy that has not been previously employed to
      investigate the effects of age and vaccine type on specific kinds of immune responses to
      licensed, seasonal 2009-2010 influenza vaccines in children and adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old
             (non-twin) or 70-100 year-old elderly non-twin adults.

          -  Willing to complete the informed consent process.

          -  Availability for follow-up for the planned duration of the study at least 28 days
             after immunization.

          -  Acceptable medical history by medical history and vital signs.

        Exclusion Criteria:

          -  Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009

          -  Allergy to egg or egg products, or to vaccine components, including gentamicin,
             gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).

          -  Life-threatening reactions to previous influenza vaccinations

          -  Asthma or history of wheezing (for volunteers randomized to LAIV)

          -  Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          -  History of immunodeficiency (including HIV infection)

          -  Known or suspected impairment of immunologic function, including, but not limited to,
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate
             to severe renal disease, or any other chronic disorder which, in the opinion of the
             investigator, might jeopardize volunteer safety or compliance with the protocol.

          -  Blood pressure >150 systolic or >95 diastolic at first study visit

          -  Hospitalization in the past year for congestive heart failure or emphysema.

          -  Chronic Hepatitis B or C.

          -  Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
             all groups; inhaled steroid use is not permissible except for non-LAIV Group only).
             Use of oral steroids (<20 mg prednisone-equivalent/day) may be acceptable for
             volunteers 70-100 yrs of age after review by the investigator.

          -  Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV

          -  Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
             such as breast cancer or prostate cancer with recurrence in the past year, and any
             hematologic cancer such as leukemia).

          -  Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
             of the investigator, might jeopardize volunteer safety or compliance with the
             protocol.

          -  History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
             medical follow up or hospitalization during the preceding year

          -  Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
             agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be
             reviewed by investigator to determine if this would affect the volunteer's safety.

          -  Receipt of blood or blood products within the past 6 months

          -  Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

          -  Inactivated vaccine 14 days prior to vaccination

          -  Live, attenuated vaccine within 60 days of vaccination

          -  History of Guillain-Barré Syndrome

          -  Pregnant or lactating woman

          -  Use of investigational agents within 30 days prior to enrollment

          -  Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

          -  Any condition which, in the opinion of the investigator, might interfere with
             volunteer safety, study objectives or the ability of the participant to understand or
             comply with the study protocol.