title: Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: a cluster randomized trial.
abstract: BACKGROUND
  School-based influenza immunization can effectively address accessibility barriers, but injected inactivated influenza vaccines (IIV) may not be acceptable to some children and parents in school settings.
  
  
  OBJECTIVE
  To better understand the feasibility of offering intranasal live attenuated influenza vaccines (LAIV) through schools, we assessed uptake, stakeholder acceptability, and cost of school-based delivery of LAIV compared to IIV.
  
  
  METHODS
  We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario during the 2013-2014 influenza vaccination campaign. Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department. We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school. Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals. We compared the costs per dose of vaccine administered, including staff time and costs of vaccines and supplies.
  
  
  RESULTS
  Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV (19.3% vs. 12.2%, p=0.02). Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines, and that LAIV was associated with increased efficiency and calmer children. All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake. The cost per vaccine dose administered was $38.67 for IIV and $43.50 for LAIV.
  
  
  CONCLUSIONS
  Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety, but also slightly higher vaccine administration costs, compared to IIV. However, uptake was low for both groups. More effective strategies to promote influenza vaccines and to obtain parent consent may improve vaccine uptake.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01995851.
  
  
  BACKGROUND
  Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network.
authors.affiliation: Public Health Ontario, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Institute for Clinical Evaluative Sciences, Toronto, ON, Canada; Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada; University Health Network, Toronto, ON, Canada. Electronic address: jeff.kwong@utoronto.ca.
authors.forename: Jeffrey C
authors.initials: JC
authors.lastname: Kwong
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Pereira
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Susan
authors.initials: S
authors.lastname: Quach
authors.affiliation: Peterborough County-City Health Unit, Peterborough, ON, Canada.
authors.forename: Rosana
authors.initials: R
authors.lastname: Pellizzari
authors.affiliation: Peterborough County-City Health Unit, Peterborough, ON, Canada.
authors.forename: Edwina
authors.initials: E
authors.lastname: Dusome
authors.affiliation: Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
authors.forename: Margaret L
authors.initials: ML
authors.lastname: Russell
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.
authors.forename: Jemila S
authors.initials: JS
authors.lastname: Hamid
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Yael
authors.initials: Y
authors.lastname: Feinberg
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Anne-Luise
authors.initials: AL
authors.lastname: Winter
authors.affiliation: Public Health Ontario, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Department of Paediatrics, University of Toronto, Toronto, ON, Canada.
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Gubbay
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Brittany
authors.initials: B
authors.lastname: Sirtonski
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Deanna
authors.initials: D
authors.lastname: Moher
authors.affiliation: Public Health Ontario, Toronto, ON, Canada.
authors.forename: Doug
authors.initials: D
authors.lastname: Sider
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Toronto Public Health, Toronto, ON, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Finkelstein
authors.affiliation: Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Mark
authors.initials: M
authors.lastname: Loeb
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D007407:Interviews as Topic; D008297:Male; D009864:Ontario; D010342:Patient Acceptance of Health Care; D010865:Pilot Projects; D012574:Schools; D013334:Students; D011795:Surveys and Questionnaires; D014611:Vaccination / Q000379:methods* / Q000706:statistics & numerical data*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated
keywords: Canada; Immunization Programs*; Influenza; Ontario; Parents*; Schools