Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)

The aim of this study is to compare the response to different formulations of licensed
influenza vaccines.

The type of seasonal influenza vaccination(s) received independently by volunteers in the
year(s) since their last study visit will not impact eligibility. Volunteers will be assigned
into one of three vaccine groups (intramuscular trivalent inactivated influenza vaccine
(TIV); live attenuated influenza vaccine (LAIV- given year 1 only) or intradermal TIV, based
on the type of study vaccine they received in 2010, 2011, 2012, or 2013. All participants
will receive a single dose of their assigned seasonal influenza vaccine. Volunteers will
complete 3 study visits at Day 0, Day 6-8 and Day 24-32.

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