Influenza Clinical Trial
Official title:
Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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