Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study was conducted in three phases. The first phase spanned from 1998-2003 (PubMed
      ID:14706961; PubMed ID: 12915495) and the second phase spanned from 2003-2007 (PubMedID:
      18401289; PubMed ID: 17698577). The final phase of the study spanned 2007-2011 and is the
      scope of this submission.

      The goal of the final phase is to control epidemic influenza through active immunization of
      healthy school-aged children with the cold-adapted, trivalent, live, attenuated influenza
      vaccine (LAIV) and at-risk children with the inactivated influenza vaccine (IIV) through a
      school-based vaccination program.

      The hypothesis is that universal vaccination of healthy school-aged children is an
      alternative and effective strategy for the control of epidemic influenza, and will serve as a
      model for the control of pandemic influenza and biodefense. The specific aims of the study
      are: to control the spread of influenza to susceptible adults 35 years of age or older by
      vaccination of school-aged children 4-18 years of age; to control the spread of influenza to
      susceptible children and young adults less than 35 years of age by vaccination of school-aged
      children 4-18 years of age; to develop a school-based vaccination program for rapid and
      timely delivery of LAIV and IIV to children 4-18 years of age; to demonstrate in school-aged
      children the direct and total effectiveness of influenza vaccines to reduce the rates of
      medically attended acute respiratory illness (MAARI) in LAIV and IIV recipients during
      influenza epidemics; and to capture safety information on LAIV post-licensure.

      This is an open-label, up to four year community-based study. In each of the first three
      study years, school-aged children (4 through 18 years of age) who receive medical care at the
      Scott & White Clinics (SWCs), Temple-Belton area, Texas, will be asked to participate in this
      study. Study participants will receive LAIV or IIV according to their health status. Other
      children from Temple-Belton area who do not receive medical care at the SWC will be invited
      to participate in the study and may receive LAIV or IIV. A comparable population enrolled in
      the SWCs in Waco/McLennan County area and Bryan/College Station will serve as comparison
      groups.

      In the fourth and final year of the study, LAIV will not be provided through the study.
      However, influenza surveillance will continue and MAARI data will be collected to assess
      continued protective benefit of influenza vaccines. The final year will also be devoted to
      completion of data analysis and preparation of manuscripts.

      Children 4 years through 8 years who have not previously been vaccinated with an influenza
      vaccine will be offered a second dose 4 to 6 weeks after the first dose. The influenza
      vaccines will contain the three influenza virus strains chosen by the FDA. Each subject will
      receive by nasal spray a 0.2 ml dose (0.1 ml in each nostril) of the LAIV or 0.5 ml
      intramuscularly.

      The duration of each study year is approximately five to ten months, from the time of
      enrollment (August to January, at the discretion of the investigators) depending on vaccine
      availability and the timing of influenza activity, to the end of the influenza season (May).
    

Intervention name(s): live attenuated and inactivated influenza vaccines
Intervention type(s): Biological
Intervention description(s): 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
Other intervention name(s): FluMist; Fluzone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza vaccine; live attenuated influenza vaccine (LAIV or FluMist); inactivated influenza vaccine (IIV); School-based influenza vaccination program; children; herd protection