Hutterite Influenza Prevention Study

Group A:

Inclusion Criteria:

• Hutterites other than the healthy children who will be immunized. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups:
• individuals aged ≥ 65 years
• children 23 months of age or less

• anyone with ≥ 1 of the following conditions severe enough to require regular medical follow-up or hospital care:

  • chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma)
  • diabetes mellitus and other metabolic diseases
  • cancer
  • immunodeficiency
  • immunosuppression (due to underlying disease and/or therapy)
  • renal disease
  • anemia
  • hemoglobinopathy
  • any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration.

Exclusion Criteria:

• There are no exclusion criteria for this category of participants.

Group B:

Inclusion Criteria:

• Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion Criteria:

• Anaphylactic reaction to a previous dose of influenza vaccine
• Anaphylactic reaction to hepatitis A vaccine
• Anaphylactic reaction to neomycin
• Known IgE-mediated hypersensitivity to eggs manifested as hives
• Swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
• Guillain-Barré syndrome within eight weeks of a previous influenza vaccine.