Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: live attenuated and inactivated influenza vaccines
Intervention description: Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received LAIV or IIV from the local healthcare providers
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29255.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza vaccine; live attenuated influenza vaccine (LAIV or FluMist); inactivated influenza vaccine (IIV); School-based influenza vaccination program; children; herd protection

Summary:

      The main purpose of this study is to learn if influenza vaccines (live attenuated and
      inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can
      stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that
      vaccination of these children will significantly reduce breathing problems (in the vaccinated
      children and unvaccinated people they come in contact with in the community) that require a
      visit to the doctor for treatment. Another purpose is to continue to collect safety and flu
      protection information on live attenuated influenza vaccine (LAIV or FluMist) given to
      children. The study investigators believe that vaccination of healthy school-aged children is
      an effective plan for preventing many people in the community from catching the flu. Children
      will take part in the study for 5 to 10 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed informed consent form by adult participant or parent/ legal guardian who are
             able to understand and comply with the protocol and assent when appropriate (usually
             age greater than or equal to 7 years)

          -  healthy subject, 4 through 18 years of age and none of the exclusion criteria

        Exclusion Criteria:

          -  history of hypersensitivity, especially anaphylactic reaction, to any components of
             FluMist™, including eggs or egg products

          -  on aspirin therapy or aspirin-containing therapy

          -  history of Guillain-Barré syndrome

          -  known or suspected immune deficiency diseases such as combined immunodeficiency,
             agammaglobulinemia, and thymic abnormalities and conditions such as human
             immunodeficiency virus infection, malignancy, leukemia or lymphoma

          -  on immunosuppressive therapies such as systemic corticosteroids, alkylating drugs,
             antimetabolites, or radiation

          -  close contact within 21 days after vaccination with immunocompromised individuals

          -  history of asthma or reactive airway disease

          -  history of chronic or underlying diseases for which the licensed inactivated flu
             vaccine (IIV-T) is recommended such as chronic disorders of the cardiovascular and
             pulmonary systems, or chronic conditions such as metabolic diseases, renal dysfunction
             or hemoglobinopathies that required medical follow-up or hospitalization during the
             preceding year

          -  concurrent use with an anti-influenza compound

          -  pregnant or plans to become pregnant within 42 days after vaccination

          -  nursing mother and

          -  any condition which, in the opinion of the investigator, interferes with evaluation of
             the vaccine