Hutterite Influenza Prevention Study

Completed

• Conditions: Influenza; Infections and Infestations; Influenza, virus not identified

• Registration Number: ISRCTN15363571
• Lead Sponsor: McMaster University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

There are two sets of participants in this trial:
1. Hutterites other than the healthy children who will be immunised. 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:
1.1. Individuals aged greater than or equal to 65 years
1.2. Pregnant women
1.3. Children 23 months of age or less
1.4. Anyone with greater than or equal to one of the following conditions severe enough to require regular medical follow-up or hospital care:
1.4.1. Chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma)
1.4.2. Diabetes mellitus and other metabolic diseases
1.4.3. Cancer
1.4.4. Immunodeficiency
1.4.5. Immunosuppression (due to underlying disease and/or therapy)
1.4.6. Renal disease
1.4.7. Anaemia
1.4.8. Haemoglobinopathy
1.4.9. Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration
2. Healthy children aged 36 months to 15 years who will be immunised as part of the intervention

Exclusion Criteria

1. Hutterites other than the healthy children who will be immunised; there are no exclusion criteria for this category of participants
2. Healthy children aged 36 months to 15 years who will be immunised as part of the intervention:
2.1. Anaphylactic reaction to a previous dose of influenza vaccine
2.2. Anaphylactic reaction to hepatitis A vaccine
2.3. Anaphylactic reaction to neomycin
2.4. Known immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
2.5. Guillain-Barre syndrome within eight weeks of a previous influenza vaccine

Study & Design

• Study Type: Interventional
• Study Design: Not specified