Randomized Evaluation of Live Attenuated vs. Trivalent Inactivated influenza VaccinEs in Schools (RELATIVES): Pilot Study
Seasonal influenza leads to significant mortality, morbidity, health service utilization, and absences from work and school, affecting both children and adults every year. School-based influenza immunization (SBII) has been considered as a strategy to increase rates of vaccine coverage among children, a group known to experience the highest rates of influenza infection in a population, thereby driving influenza epidemics through virus transmission to peers and household contacts. However, preliminary results of a current study involving focus groups of Ontario parents indicate that while the convenience of these programs is a substantial benefit, several concerns remain including children being afraid of needles and requiring comfort they cannot get from their parent through a school-based program. An alternative to the conventional vaccine injection is the intranasal, live attenuated influenza vaccine (LAIV). LAIV was first approved for use in the United States in 2003 and was more recently approved for use in Canada in 2010. Guidelines from the National Advisory Committee on Immunization recommend it over trivalent inactivated influenza vaccine (TIV) for healthy children between 2 and 17 years, based of efficacy, effectiveness, and immunogenicity data. However, at this time, only TIV is publicly funded in Ontario, and current school-based immunization programs with TIV in this province have vaccine coverage rates of 30% on average.
We propose to conduct a pilot study in the fall of 2013 to evaluate the use of LAIV via SBII in 10 schools within the geographic boundaries of Peterborough County-City Health Unit in order to determine the effect of vaccine type (LAIV vs. TIV) on vaccine coverage, to assess the feasibility of such a program based on acceptability and costs, and to inform a larger randomized controlled trial (RCT) to understand the direct and indirect benefits of LAIV for reducing influenza incidence.