Status:
COMPLETED
Hutterite Influenza Prevention Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Influenza
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other col...
Detailed Description
Colonies will be enrolled in September 2008. Healthy Hutterite Children will be vaccinated in October, in each year of the study (2008, 2009, \& 2010) Influenza Surveillance phase will begin around ...
Eligibility Criteria
Inclusion
- Group A:
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
4771 Patients enrolled
Trial Details
Trial ID
NCT00877396
Start Date
September 1 2008
End Date
July 1 2011
Last Update
September 28 2011
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