Self-Administered Nasal Influenza Feasibility Study
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluMist
Intervention description: FluMist Intranasal Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1077.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza

Summary:

      The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity
      of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with
      healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group
      self-administration of LAIV.
    

Eligibility criteria:

        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.