Background: Influenza 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.

Purpose: Determine the feasibility, sustainability, and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day.

Design: In 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/participants: Intervention 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).

Intervention: After gathering parental consent and insurance information, live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day.

Main outcome measures: Data 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.

Results: Results 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).

Conclusions: Delivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage.

Trial registry: ClinicalTrials.govNCT01224301.