Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone® (IM); Fluzone® Intradermal (ID); 2011-2012 FluMist®
Intervention description: This vaccine is given intramuscularly (IM); This vaccine is given intradermally (ID); 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: 86.0
Sex: All
Minimum age: 8 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intramuscular inactivated trivalent influenza vaccine; Intradermal inactivated trivalent influenza vaccine; Live, attenuated influenza vaccine; Young adults

Summary:

      The purpose of this study is to investigate the responses to licensed trivalent, inactivated
      influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal
      (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all
      given to generally healthy male and female adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy, ambulatory between the ages of 8-33 years, inclusively.

          -  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 and vital signs

        Exclusion Criteria:

          -  Prior vaccination with seasonal TIV or LAIV

          -  Prior off-study vaccination with TIV or LAIV in the current flu season

          -  Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose
             vials only)

          -  Life-threatening reactions to previous influenza vaccinations

          -  Active systemic or serious concurrent illness, including febrile illness on the day of
             vaccination

          -  Asthma or history of wheezing (for volunteers receiving LAIV only)

          -  Participants in close contact with anyone who has a severely weakened immune system
             should not receive LAIV (for volunteers receiving LAIV only)

          -  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

          -  Chronic Hepatitis B or C

          -  Recent or current use of immunosuppressive medication, including systemic
             glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids
             are permissible in both groups)

          -  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. aspirin 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 or planned receipt of
             blood products prior to completion of study visits

          -  Medical or psychiatric condition or occupational responsibilities that preclude
             participant compliance with the protocol

          -  Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination
             prior to completion of Visit 03 (~Day 28 after the study vaccination)

          -  Live, attenuated vaccine within 60 days of vaccination or planned non-study
             vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)

          -  Need an allergy immunization (that cannot be postponed) during the study period V01 to
             V03 (~Day 28)

          -  History of Guillain-Barré Syndrome

          -  Pregnant or lactating woman

          -  Use of investigational agents within 30 days prior to enrollment or planned use of
             investigational agents prior to completion of study visits

          -  Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
             planned blood donation prior to completion of study visits

          -  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