Seasonal Influenza Vaccination at School: A Randomized Controlled Trial

BackgroundInfluenza vaccination coverage for U.S. school-aged children is below the 80% national goal. Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season. No real-world models of school-located seasonal influenza (SLV-I) programs have been tested.PurposeDetermine the feasibility, sustainability, and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day.DesignIn this pragmatic randomized controlled trial of SLV-I during two vaccination seasons, schools were randomly assigned to SLV-I versus standard of care. Seasonal influenza vaccine receipt, as recorded in the state immunization information system (IIS), was measured.Setting/participantsIntervention and control schools were located in a single western New York county. Participation (intervention or control) included the sole urban school district and suburban districts (five in Year 1, four in Year 2).InterventionAfter gathering parental consent and insurance information, live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day.Main outcome measuresData on receipt of ≥1 seasonal influenza vaccination in Year 1 (2009-2010) and Year 2 (2010-2011) were collected on all student grades K through 5 at intervention and control schools from the IIS in the Spring of 2010 and 2011, respectively. Additionally, coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere. Preliminary data analysis for Year 1 occurred in Spring 2010; final quantitative analysis for both years was completed in late Fall 2012.ResultsResults are shown for 2009-2010 and 2010-2011, respectively: Children enrolled in suburban SLV-I versus control schools had vaccination coverage of 47% vs 36%, and 52% vs 36% (p<0.0001 both years). In urban areas, coverage was 36% vs 26%, and 31% vs 25% (p<0.001 both years). On multilevel logistic analysis with three nested levels (student, school, school district) during both vaccination seasons, children were more likely to be vaccinated in SLV-I versus control schools; ORs were 1.6 (95% CI=1.4, 1.9; p<0.001) and 1.5 (95% CI=1.3, 1.8; p<0.001).ConclusionsDelivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage.Trial RegistryClinicalTrials.govNCT01224301