Despite immunization of high risk persons against influenza, annual epidemics continue to pose an important threat to the health of persons over the age of 65 years as well as to persons with cardiopulmonary and other high risk conditions. Healthy children are felt to be an important source for community transmission of influenza. Immunizing school-aged children has been proposed as one strategy to protect high risk individuals; by immunizing children spread of influenza is prevented and persons at high risk for complications are protected. 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 majority of Hutterites live in Alberta, Saskatchewan, and Manitoba where they practice communal farming on small colonies isolated from towns and cities. We propose 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. We believe that the trial we propose will lead to important data that can inform policy on influenza immunization strategy. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI076208-01A1
Application #
7527413
Study Section
Special Emphasis Panel (ZAI1-BDP-M (M2))
Program Officer
Lambert, Linda C
Project Start
2008-09-30
Project End
2011-08-31
Budget Start
2008-09-30
Budget End
2009-08-31
Support Year
1
Fiscal Year
2008
Total Cost
$499,999
Indirect Cost
Name
Mcmaster University
Department
Type
DUNS #
207510108
City
Hamilton
State
ON
Country
Canada
Zip Code
L8 3-Z5
Science, Michelle; Maguire, Jonathon L; Russell, Margaret L et al. (2017) Prevalence and predictors of low serum 25-hydroxyvitamin D levels in rural Canadian children. Paediatr Child Health 22:125-129
Verschoor, Chris P; Singh, Pardeep; Russell, Margaret L et al. (2015) Microneutralization assay titres correlate with protection against seasonal influenza H1N1 and H3N2 in children. PLoS One 10:e0131531
Science, Michelle; Maguire, Jonathon L; Russell, Margaret L et al. (2014) Serum 25-hydroxyvitamin d level and influenza vaccine immunogenicity in children and adolescents. PLoS One 9:e83553
Science, Michelle; Maguire, Jonathon L; Russell, Margaret L et al. (2013) Low serum 25-hydroxyvitamin D level and risk of upper respiratory tract infection in children and adolescents. Clin Infect Dis 57:392-7