Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Live attenuated Influenza vaccine; Trivalent Influenza Vaccine; TIV followed by LAIV; LAIV followed by TIV
Intervention description: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days; .25 mL given intramuscularly to children 24 to 36 months of age, 2 doses given 28 days apart, .5 mL given intramuscularly to children 37 months to 9 years of age, 2 doses given 28 day s apart.; TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later; LAIV .2 mL given through nasal spray (.1 mL in each nostril) Followed by TIV .25 mL given intramuscularly to children 24 to 25 months of age or .5 mL given intramuscularly to children 36 months to 9 years of age 28 days later
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; A/California/7/2009-like (2009 H1N1); A/Perth/16/2009-like (H3N2); B/Brisbane/60/2008-like (B/Victoria lineage)

Summary:

      A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose
      schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or
      licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed
      by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1
      infection will be excluded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 2 and 9 years, inclusive.

          -  No prior history of laboratory documented infection with novel H1N1 virus

          -  The subject must be in good health, as determined by: vital signs (heart rate <140
             bpm; blood pressure: systolic ≥ 90 mm Hg and ≤140 mm Hg; diastolic ≤ 90 mm Hg; oral
             temperature <100.0ºF (fahrenheit); medical history; and targeted physical examination,
             when necessary, based on medical history. Stable medical condition is defined as: no
             recent increase in prescription medication, dose, or frequency of medication in the
             last 3 months and health outcomes of the specific disease are considered to be within
             acceptable limits in the last 6 months.

          -  The subject/parents are able to understand and comply with the planned study
             procedures, including being available for all study visits.

          -  The subject/parents have provided informed consent prior to any study procedures. (An
             assent will be obtained for all children as required by the institutional IRB
             (Institutional Review Board.)

        Exclusion Criteria:

          -  Subjects with a laboratory documented history of previous novel H1N1 infection.

          -  History of egg allergy or allergy to other components of vaccine.

          -  History of wheezing.

          -  The subject is immunosuppressed as a result of an underlying illness or treatment with
             immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
             therapy.

          -  The subject has an active neoplastic disease.

          -  The subject has long-term (greater than 2 weeks) use of oral or parenteral steroids,
             or high-dose inhaled steroids (>800 mg/day of beclomethasone dipropionate or
             equivalent) within the preceding 6 months (nasal and topical steroids are allowed).

          -  The subject received immunoglobulin or another blood product within the 3 months prior
             to enrollment in this study.

          -  The subject has received an inactivated vaccine within the 2 weeks or a live vaccine
             within the 4 weeks prior to enrollment in this study or plans to receive another
             vaccine within the next 28 days (or 56 days for vaccine naïve recipients).

          -  The subject has an acute or chronic medical condition that, in the opinion of the
             investigator, would render vaccination unsafe or would interfere with the evaluation
             of responses. These conditions include chronic conditions recognized as risk factors
             for influenza complications or as contraindications for live vaccination, including
             chronic cardiac (exclusive of hypertension) or pulmonary conditions (including
             asthma), diabetes mellitus, or renal impairment.

          -  The subject has an acute illness or an oral temperature greater than 99.9 degreesF
             (37.7 degrees C) within 3 days prior to enrollment or vaccination. Subjects who had an
             acute illness that was treated symptoms resolved are eligible to enroll as long as
             treatment is completed and symptoms resolve > 3 days prior to enrollment.

          -  The subject is currently participating or plans to participate in a study that
             involves an experimental agent (vaccine, drug, biologic, device, blood product, or
             medication) or has received an experimental agent within 1 month prior to enrollment
             in this study, or expects to receive another experimental agent during participation
             in this study, or intends to donate blood during the study period.

          -  The subject has any condition that would, in the opinion of the site investigator,
             place the subject at an unacceptable risk of injury or render the subject unable to
             meet the requirements of the protocol.

          -  The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C
             infection.

          -  The subject has a previous history of Guillain-Barré syndrome within 6 weeks of
             receipt of influenza vaccination.

          -  The subject has any condition that the principal investigator (PI) believes may
             interfere with successful completion of the study.