Hutterite Influenza Prevention Study

Study Overview
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Brief Summary
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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 colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.

Detailed Description
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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 December-January of each year. All study outcomes will be collected during the Surveillance phase of the study from Dec to June for 3 years. Outcomes will be collected when research nurses visit the colonies. A research nurse will visit enrolled colonies twice a week during the surveillance phase and review study diaries and obtain swabs from participants with symptoms of influenza.

Official Title
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Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza vaccination
* Biological: Hepatitis A Vaccine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Influenza<br>Inactivated Influenza vaccination | Biological: Influenza vaccination<br>* Influenza vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose (0.5 mL) 4 weeks later.<br>* Other names: Vaxigrip by Sanofi Pasteur;|
| Placebo Comparator: Control<br>Hepatitis A vaccine | Biological: Hepatitis A Vaccine<br>* Hepatitis vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose ( saline- 0.5 mL) 4 weeks later.<br>* Other names: Avaxim Pediatric by Sanofi Pasteur;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory-confirmed influenza infection |  | Dec to June each year for 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza like illness |  | Dec to June each year for 3 years | 
| Physician diagnosed otitis media |  | Dec to June each year for 3 years | 
| School or work related absenteeism |  | Dec to June each year for 3 years | 
| Physician visits for respiratory illness |  | Dec to June each year for 3 years | 
| Lower respiratory infection or pneumonia |  | Dec to June each year for 3 years | 
| Hospitalizations for LRTI or pneumonia |  | Dec to June each year for 3 years | 
| All cause hospitalizations |  | Dec to June each year for 3 years | 
| Deaths due to LRTI or pneumonia |  | Dec to June each year for 3 years | 
| All-cause deaths |  | Dec to June each year for 3 years |