Self-Administered Nasal Influenza Feasibility Study

Inclusion Criteria:

- Healthy males or healthy, non-pregnant females

- 18-49 years of age

- Department of Defense beneficiary including active duty members

- Able to speak and understand English, and provide written informed consent

Exclusion Criteria:

- Known hypersensitivity to eggs, egg-proteins, gentamicin, gelatin, or arginine or
life-threatening reactions to previous influenza vaccination

- Prior receipt of the 2012-2013 seasonal influenza vaccine for 2012-2013 season or
prior receipt of the 2013-2014 seasonal influenza vaccine for 2013-2014 season

- Known clinical diagnosis of reactive airway disease, wheezing, or asthma (excluding
exercise-induced asthma)

- Reported febrile upper respiratory illness (oral or tympanic temperature greater than
100°F or a subjective fever) at the time of or within the 24 hours prior to
immunization

- Known to be pregnant, possibly pregnant or breast-feeding

- Known diagnosis of human immunodeficiency virus (HIV) infection, chronic active
hepatitis B infection, or chronic hepatitis C infection

- History of Guillain-Barre Syndrome

- Household member known to be immunocompromised (either a known disease or disorder
such as HIV, or other acquired or congenital immunodeficiency disorder, or taking
systemic steroids (any dose) or high daily dose inhaled steroids, tumor necrosis
factor-alpha inhibitors, or monoclonal antibodies used to treat autoimmune disease)

- Receipt of medications with activity against influenza A and/or B (ex: Tamiflu®,
Relenza®, amantadine, or rimantadine) within 48 hours prior to vaccine administration

- Use of any oral or intravenous systemic steroids (any dose) or any daily dose inhaled
steroids

- At the time of enrollment, any person who is trained to administer intranasal
vaccines or who has been involved in any recurring role associated with the
administration of intranasal vaccines to others in the clinic or military treatment
facility (MTF)

- Prior participation in this research study

- 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
may include, but are not limited to: history of significant renal impairment
(dialysis and treatment for kidney disease, including diabetic and hypertensive
kidney disease); poorly controlled diabetes mellitus or patients with diabetes
mellitus on insulin (subjects with well-controlled diabetes mellitus on oral agents
may enroll as long there has been no dosage increase within the past 6 months);
cardiac insufficiency, if heart failure is present; 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).

- If the individual received a live virus vaccine (e.g., Varicella,
Measles-Mumps-Rubella, Yellow Fever, Smallpox) in the past 4 weeks, they should wait
28 days before receiving LAIV. There is no reason to defer vaccination if the
individual was vaccinated with an inactivated vaccine or if they have recently
received blood or other antibody-containing blood products.